FDA Calendar

Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.

Exact Dates

Estimated Dates

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VERA
Vera Therapeutics, Inc.
Atacicept
Patients with IgAN
Phase 3
10/17/2025
9:12 AM
Data

Vera Therapeutics, Inc. announced that data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be delivered as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas, being held November 6 to 9.

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OST-HER2
In patients with HER2-expressing solid tumors in breast cancer and other cancers
Type C Meeting
10/17/2025
9:15 AM
FDA Approval

OS Therapies Inc. announced that the United States Food & Drug Administration ("FDA") has granted a second Type C Meeting, following its successful End of Phase 2 Meeting.

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VRTX
Vertex Pharmaceuticals Inc
povetacicept
in IgA nephropathy
10/17/2025
9:04 AM
Provided Update

Vertex Pharmaceuticals Incorporated announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases.

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DISC-0974
For the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
10/17/2025
9:00 AM
Data Presentation

Disc Medicine, Inc. nnounced it will present clinical data as a poster presentation at the upcoming 2025 American Society of Nephrology (ASN) Kidney Week, which will be held in Houston, TX on November 6-9, 2025.

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NVSNVSEF
Novartis AG
Kisqali® (ribociclib)
For breast cancer
10/17/2025
8:33 AM
Results

Novartis announced results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali® (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.

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NBIX
Neurocrine Biosciences Inc
INGREZZA (Valbenazine)
Tardive Dyskinesia
10/17/2025
8:30 AM
Presentation

Neurocrine Biosciences, Inc. announced the presentation of a new post-hoc analysis from the Phase 3, open-label KINECT® 4 study, demonstrating that patients treated continuously for 48 weeks with the 40 mg dose of once-daily INGREZZA® (valbenazine) capsules experienced clinically meaningful improvements in tardive dyskinesia symptoms.

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PHGEPHGE.U
BiomX Inc
BX004
Cystic Fibrosis
10/17/2025
8:30 AM
Provided Update

BiomX Inc today provided an update on progress relating to the previously disclosed U.S. Food and Drug Administration (FDA) clinical hold placed on the U.S. portion of the BX004 Phase 2b trial in cystic fibrosis (CF).

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SNSE
Sensei Biotherapeutics
Solnerstotug
in PD-(L)1 Resistant Tumors
Phase 1/2
10/17/2025
8:16 AM
Results

Sensei Biotherapeutics, Inc announced results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation).

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EVX-01
Metastatic Melanoma
10/17/2025
8:15 AM
Efficacy Data

Evaxion A/S announces new two-year unprecedented clinical efficacy data of its personalized cancer vaccine EVX-01 in patients with advanced melanoma.

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AGIO
Agios Pharmaceuticals Inc
Mitapivat
Sickle cell disease
European Medicines Agency (EMA)
10/17/2025
8:15 AM
Positive Opinion

Avanzanite Bioscience B.V. reported that its partner Agios Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the new indication for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.

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IMNN-101
SARS CoV-2
10/17/2025
8:10 AM
Oral presentation

IMUNON, Inc. announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company's proprietary PlaCCine® technology platform, including proof-of-concept clinical trial results at the following upcoming vaccine conferences:

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AGEN
Agenus Inc
Botensilimab + balstilimab
Metastatic heavily pretreated microsatellite stable colorectal cancer
10/17/2025
8:10 AM
New Data

Agenus Inc. announced new data from its botensilimab (BOT), a multifunctional, Fc-enhanced CTLA-4 antibody and balstilimab (BAL), a PD-1 inhibitor, combination demonstrating durable survival across multiple cancer types in late-stage patients who have limited treatment options.

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LLY
Eli Lilly and Co
Verzenio plus endocrine therapy
in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.
Phase 3
10/17/2025
8:05 AM
Analysis

Eli Lilly and Company announced results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial showing that two years of adjuvant Verzenio plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.

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AZNAZNCF
AstraZeneca PLC
Durvalumab
Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
Phase 3
10/17/2025
8:00 AM
Positive Results

Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) versus chemotherapy alone.

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KNSA
Kiniksa Pharmaceuticals Ltd
KPL-387
In recurrent pericarditis
Orphan Drug Designation
10/17/2025
8:00 AM
Designation Grant

Kiniksa Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis.

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SNSE
Sensei Biotherapeutics
SNS-101
Suppressor of T cells by binding the receptor PSGL-1
Phase 1/2
10/17/2025
8:00 AM
Results

Sensei Biotherapeutics, Inc. announced results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation).

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VOR
Vor Biopharma
telitacicept
Sjögren's Disease
Phase 3
10/17/2025
8:00 AM
Clinical Data

Vor Bio announced that clinical data from Stage A of a Phase 3 study in China sponsored by Vor Bio's collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), which evaluated telitacicept in adults with IgA neuropathy (IgAN), will be presented as a late-breaking oral presentation at American Society of Nephrology's (ASN) Kidney Week 2025 being held Nov 5-9, 2025, in Houston, Texas.

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REGNSNYSNYNF
Regeneron Pharmaceuticals Inc
Sanofi SA
Libtayo (cemiplimab)
Advanced Cervical Cancer
10/17/2025
7:30 AM
Positive Opinion

Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

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ACHV
Achieve Life Sciences Inc
cytisinicline
For the treatment of nicotine dependence
10/17/2025
7:30 AM
Provided Update

Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation.

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INSM
Insmed Inc
Brensocatib
In Patients with Bronchiectasis
European Medicines Agency (EMA)
10/17/2025
7:00 AM
Positive Opinion

Insmed Incorporated announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of its DPP1 inhibitor BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months

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SMMT
Summit Therapeutics Inc
Ivonescimab
For Lung cancer
Phase 3
10/17/2025
7:00 AM
Expansion

Summit Therapeutics Inc. announced the expansion of its Phase III clinical development program of the novel, potential first-in-class investigational bispecific antibody, ivonescimab, into colorectal cancer (CRC) with the initiation of the global Phase III HARMONi-GI3 trial.

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PFE
Pfizer Inc
Dovato
For adolescents living with HIV
10/17/2025
7:00 AM
Findings Update

ViiV Healthcare and Pfizer announced 96-week findings from PASO DOBLE (GeSIDA 11720 study) showing that Dovato (dolutegravir/lamivudine [DTG/3TC]) is as effective as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) in maintaining virological suppression in adults with HIV-1.

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tegoprubart
For Type 1 Diabetes
10/17/2025
7:00 AM
Oral presentation

Eledon Pharmaceuticals, Inc. announced an oral presentation will be featured at the American Society of Nephrology's upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025.

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TNXP
Tonix Pharmaceuticals Holding Corp
TNX-801
Potential Vaccine to Prevent Mpox and Smallpox
10/17/2025
7:00 AM
Oral presentation

Tonix Pharmaceuticals presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands.

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CLYM
Climb Bio Inc
CLYM116
for IgAN
10/17/2025
7:00 AM
Upcoming presentations

Climb Bio, Inc. announced the upcoming presentation of CLYM116 preclinical data and published budoprutug pMN Phase 1b long-term outcome data at the 2025 American Society of Nephrology (ASN) Kidney Week, which will be held in Houston, TX November 6-9, 2025.

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PLX
Protalix BioTherapeutics Inc
ProCellEx
Plant cell based protein expression system
European Medicines Agency (EMA)
10/17/2025
6:58 AM
Negative opinion

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. acknowledge that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio (pegunigalsidase alfa, in addition to the currently approved dosing regimen of 1 mg/kg body weight infused every 2 weeks (E2W).

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QDEL
QuidelOrtho Corporation
ORTHO VISION
for patients who depend on timely transfusion decisions.
10/16/2025
8:30 PM
Highlights

QuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting.

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bitopertin
In patients with erythropoietic protoporphyria (EPP)
10/16/2025
5:39 PM
Provided Update

Disc Medicine, Inc. announced that it received a Commissioner's National Priority Voucher (CNPV) from the U.S. Food and Drug Administration (FDA) for bitopertin in erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP).

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ATAI
atai Life Sciences N.V.
BPL-003
In Patients With Treatment Resistant Depression
Breakthrough Therapy Designation
10/16/2025
4:10 PM
Designation Grant

atai Life Sciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).

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ABUS
Arbutus Biopharma Corp
AB-101
Oral PD-L1 inhibitor
Fast Track Designation
10/16/2025
4:08 PM
Designation Grant

Artiva Biotherapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AlloNK® (also known as AB-101) for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab and that the Company has prioritized refractory RA as the program's lead indication.

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TSHA
Taysha Gene Therapies Inc
TSHA-102
Rett Syndrome
10/16/2025
4:06 PM
clinical program

Taysha Gene Therapies, Inc. announced that the Company has regained full rights to its lead TSHA-102 program in clinical evaluation for Rett syndrome.

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NVSNVSEF
Novartis AG
iptacopan
To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
Phase 3
10/16/2025
10:50 AM
Results

Novartis A/S shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).

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PSNLAZNAZNCF
Personalis Inc
AstraZeneca PLC
NeXT Personal
in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
10/16/2025
9:08 AM
New Data

Personalis, Inc. announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA).

SCNX
SCIENTURE HOLDINGS Inc
Arbli
for hypertension
10/16/2025
9:00 AM
Provided Update

SCIENTURE HOLDINGS announced that Arbli™ (losartan potassium) Oral Suspension, 10mg/mL, is commercially available through full-line wholesalers nationwide.

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ENTX
Entera Bio Ltd
EB613
Parathyroid hormone (1-34), or PTH for osteoporosis
Phase 2
10/16/2025
8:45 AM
Clinical Data

Entera Bio Ltd. announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida.

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OMER
Omeros Corp
Narsoplimab
Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
10/16/2025
8:30 AM
Publication

Omeros Corporation announced the publication of a peer-reviewed manuscript in Blood Advances, a journal of the American Society of Hematology,detailing survival outcomes in adult patients with life-threatening transplant-associated thrombotic microangiopathy (TA-TMA) treated with narsoplimab across both the pivotal clinical trial and the global expanded access program (EAP).

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MBOT
Microbot Medical Inc
LIBERTY® Robotic Surgical System
Device
10/16/2025
8:30 AM
Provided Update

Microbot Medical Inc. announced that it will be exhibiting the LIBERTY® System at the upcoming Symposium on Clinical Interventional Oncology annual meeting (CIO), being held in Miami, FL on October 17-19.

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ALGS
Aligos Therapeutics Inc
ALG-000184
Hepatitis B
10/16/2025
8:30 AM
Provided Update

Aligos Therapeutics, Inc. announced that the United States Adopted Names (USAN) Council has adopted pevifoscorvir sodium as the nonproprietary (generic) name for ALG-000184, under investigation for the treatment of chronic hepatitis B virus (HBV) infection.

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NXTC
NextCure Inc
SIM0505
in patients with advanced solid tumors.
10/16/2025
8:09 AM
Dose Update

NextCure, announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.

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JNJ
Johnson & Johnson
TECVAYLI
For patients with newly diagnosed multiple myeloma
Phase 3
10/16/2025
8:00 AM
Top-line results

Johnson & Johnson announced positive topline results from the investigational Phase 3 MajesTEC-3 study.

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ESPR
Esperion Therapeutics Inc
ESP-2001
Treatment of Primary Sclerosing Cholangitis
10/16/2025
8:00 AM
Provided Update

Esperion announced the nomination of ESP-2001, the Company's highly-specific allosteric ATP citrate lyase (ACLY) inhibitor, as preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC).

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VOR
Vor Biopharma
telitacicept
Sjögren's Disease
Phase 3
10/16/2025
8:00 AM
Results

Vor Bio announced that results from a Phase 3 study in China evaluating telitacicept in systemic lupus erythematosus (SLE) sponsored by its collaborator, RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331), were published in The New England Journal of Medicine (NEJM).

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NVCT
Nuvectis Pharma, Inc.
NXP900
Novel inhibitor of the SRC family of kinases
10/16/2025
8:00 AM
Upcoming presentations

Nuvectis Pharma, Inc announced upcoming poster presentations for NXP900 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 in Boston, MA.

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INSM
Insmed Inc
Brensocatib
In Patients with Bronchiectasis
Phase 3
10/16/2025
7:00 AM
Abstract

Insmed Incorporated announced that it will present six abstracts from the Phase 3 ASPEN study of BRINSUPRI™ (brensocatib) at CHEST 2025, the American College of Chest Physicians Annual Meeting, taking place October 19 - October 22, 2025, in Chicago, IL.

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ACET
Adicet Bio Inc
ADI-001
B cell non-Hodgkin's lymphoma (NHL)
Phase 1
10/16/2025
7:00 AM
Dose Update

Adicet Bio, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory RA.

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XELAXELAU
Exela Technologies Inc
Ulixacaltamide
Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity.
Phase 3
10/16/2025
7:00 AM
Positive Results

Praxis Precision Medicines, Inc. announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET).

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DNTH212
BDCA2 and BAFF/APRIL inhibitor.
10/16/2025
7:00 AM
Provided Update

Dianthus Therapeutics, Inc. announced it has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. ("Leads" (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor.

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CLLSCMVLF
Cellectis SA
UCART22
For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
10/16/2025
7:00 AM
Provided Update

Cellectis today hosts a R&D Day in New York City.

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MRK
Merck & Co Inc
KEYNOTE-B96
In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Phase 3
10/16/2025
6:45 AM
Secondary Endpoint

Merck announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival (OS) for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers.

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MIRA
MIRA PHARMACEUTICALS, INC.
MIRA-55
Potential treatment for anxiety and cognitive decline.
10/15/2025
4:06 PM
New Data

MIRA Pharmaceuticals, Inc. (the “Company”) announced new preclinical data for Mira-55, its proprietary non-psychotropic marijuana analog, showing that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.

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SONN
Sonnet BioTherapeutics Holdings Inc
SON-1010
Advanced Solid Tumors
10/15/2025
10:03 AM
Provided Update

Sonnet BioTherapeutics Holdings is collaborating with Spanios on a non-clinical study using New Alternate Methodologies (NAM)-based patient-derived tumoroid (PDT) platforms that emulate the tumor microenvironment (TME) ex vivo to evaluate the effect of SON-1010 (IL-12-FHAB) in soft tissue sarcoma.

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DurAVR® Transcatheter Heart Valve
in patients with severe calcific aortic stenosis
10/15/2025
9:18 AM
Regulatory Update

Anteris Technologies Global Corp announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the "PARADIGM Trial").

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ARTL
Artelo Biosciences Inc
ART26.12
For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
10/15/2025
9:18 AM
Data Presentation

Artelo Biosciences, announced that Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo Biosciences, is presenting expanded data from Artelo's lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, Single Ascending Dose (SAD) Study at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit, taking place October 15–16, 2025, in Boston, Massachusetts.

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NNVC
Nanoviricides Inc
NV-387
For MPox and Smallpox virus infections
10/15/2025
8:45 AM
Publication

NanoViricides, Inc reports that an analyst research report was published on the Company that explains its dual-track, rapid clinical development strategy for NV-387, going after MPox and also after all respiratory viral infections, that include Influenzas, Coronaviruses, RSV among others.

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BLTE
Belite Bio, Inc.
Tinlarebant
In Stargardt Disease
New Drug Application (NDA)
10/15/2025
8:00 AM
Regulatory Update

Belite Bio, Inc. announced that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

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ABS-201
for androgenetic alopecia
10/15/2025
8:00 AM
Provided Update

Absci announced the company will host a virtual seminar on December 11, 2025 at 10:00am ET focused on the company's ABS-201 (anti-PRLR) program for androgenetic alopecia.

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MNPR
Monopar Therapeutics Inc
ALXN1840-WD-204
Liver Diseases
Phase 2
10/15/2025
8:00 AM
Abstract

Monopar Therapeutics Inc announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025..

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APRE
Aprea Therapeutics Inc
ATRN-119
in patients with advanced solid tumors.
Phase 2
10/15/2025
8:00 AM
Dosing Update

Aprea Therapeutics announced that it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors.

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STXS
Stereotaxis Inc
Synchrony™ system.
for Synchrony Surgical Robotics System
European Union CE Mark
10/15/2025
7:35 AM
Regulatory Update

Stereotaxis announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the US for the Synchrony™ system.

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tafenoquine
For treatment of babesiosis
10/15/2025
7:16 AM
Provided Update

60 Degrees Pharmaceuticals, announced that the first patient to have completed the regimen in the Company's trial of relapsing babesiosis in immunosuppressed patients has tested negative for babesiosis. The trial is an expanded access study of ARAKODA® (tafenoquine) in combination with conventional treatments for relapsing babesiosis (NCT06478641).

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NVCR
NovoCure Ltd
gemcitabine and nab-paclitaxel (GnP)
first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone.
10/15/2025
7:00 AM
Data Presentation

Novocure announced that it will present data at two upcoming oncology congresses, the 2025 European Association of Neuro-Oncology (EANO) Meeting, being held October 16-19 in Prague, Czech Republic, and the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany.

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GYRE
Gyre Therapeutics
pirfenidone
In Oncology-Related Pulmonary Complications
Phase 3
10/15/2025
7:00 AM
Enrollment Update

Gyre Therapeutics announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis.

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LLY
Eli Lilly and Co
orforglipron
Orforglipron for the treatment of obesity and overweight
Phase 3
10/15/2025
6:45 AM
Top-line results

Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the second head-to-head trial in the program, evaluated orforglipron versus dapagliflozin, an SGLT-2 inhibitor, in adults with type 2 diabetes inadequately controlled on metformin.

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MRK
Merck & Co Inc
Doravirine/Islatravir
In adults with HIV-1 infection
Phase 3
10/15/2025
6:45 AM
Additional data

Merck announced today the presentation of additional data from the Phase 3 studies of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that was virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50 mg/200 mg/25 mg)] in trial MK-8591A-052 or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051.

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AUPAUPH
Aurinia Pharmaceuticals Inc
LUPKYNIS (voclosporin)
Lupus Nephritis
10/15/2025
6:02 AM
Poster Presentation

Aurinia Pharmaceuticals Inc. announced that five posters will be presented in collaboration with independent investigators highlighting new data on LUPKYNIS® (voclosporin) at the American College of Rheumatology (ACR) Convergence 2025, taking place in Chicago, IL, October 24–29, and the American Society of Nephrology (ASN) Kidney Week 2025, taking place in Houston, TX, November 5–9.

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ARGNFARGX
argenx SE
VYVGART (efgartigimod alfa)
For Adults with Primary Immune Thrombocytopenia
10/15/2025
1:00 AM
Data Presentation

argenx SE a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, will present data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) and pipeline candidate empasiprubart at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29-November 1, 2025.

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ACOGF
Alpha Cognition Inc.
ALPHA-1062
Mild to Moderate Alzheimer's Disease
10/14/2025
4:30 PM
Clinical Update

Alpha Cognition Inc. announced it will present new clinical insights on cholinesterase inhibitors and ZUNVEYL® (Benzgalantamine) at two upcoming scientific meetings: the American Society of Consultant Pharmacists (ASCP) Annual Meeting (October 23–25, 2025) and the Neuroscience Education Institute (NEI) Annual Congress (November 6–9, 2025).

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XNCR
Xencor Inc
XmAb819
patients with clear cell renal cell carcinoma
10/14/2025
12:45 PM
Upcoming presentations

Xencor, Inc. announced the upcoming presentation of initial results from the ongoing Phase 1 dose-escalation study of XmAb819, a bispecific ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC) in a poster at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, Massachusetts.

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IGC-AD1
For Agitation in Alzheimer's disease.
Phase 2
10/14/2025
9:00 AM
Expansion

IGC Pharma, Inc. announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease.

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CELU
Celularity Inc.
PDA-002
For treating Facioscapulohumeral Muscular Dystrophy (FSHD).
Phase 2
10/14/2025
8:45 AM
Publication

Celularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal.

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CLRB
Cellectar Biosciences Inc
CLR 121225
For pancreatic cancer
10/14/2025
8:30 AM
Preclinical Data

Cellectar Biosciences, announced that Jarrod Longcor, chief operating officer of Cellectar, presented positive preclinical data in a poster at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research that took place from September 28 through October 1, 2025, in Boston, Massachusetts.

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IMNN-001
For ovarian cancer
Phase 3
10/14/2025
8:20 AM
Abstract

IMUNON announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, was accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21, 2025 in Berlin, Germany.

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VOR
Vor Biopharma
telitacicept
Sjögren's Disease
10/14/2025
8:12 AM
Positive Results

Vor Bio announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), reported positive 48-week results from its Phase 3 study conducted in China evaluating telitacicept in primary Sjögren's disease.

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KRYS
Krystal Biotech Inc
KB801
For the Treatment of Neurotrophic Keratitis
Platform technology designation
10/14/2025
8:09 AM
Designation Grant

Krystal Biotech, Inc. announced today that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK).

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NCNA
NuCana PLC
NuTide:303
In medRxiv And PLOS ONE
10/14/2025
8:07 AM
Data Publication

NuCana plc announced the publication of new data on NUC-3373.

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TTX-MC138
metastatic disease
Phase 1a
10/14/2025
8:06 AM
Clinical Trial

TransCode Therapeutics, Inc. announces completion of Phase 1a clinical trial with TTX-MC138, an investigational inhibitor of microRNA-10b, or miR-10b.

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Telomir-1
Potential treatment for age-related conditions
10/14/2025
8:00 AM
Findings Update

Telomir Pharmaceuticals, Inc. announced new laboratory findings demonstrating that Telomir-1 kills aggressive pancreatic cancer cells.

CADL
Candel Therapeutics, Inc.
CAN-3110
Recurrent high-grade Glioma
10/14/2025
8:05 AM
Interim Data

Candel Therapeutics, Inc announced encouraging interim data from its ongoing phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma, and a publication in the high-impact scientific journal Science Translational Medicine..

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CRBP
Corbus Pharmaceuticals Holdings Inc
CRB-701
Targets the expression of Nectin-4 on cancer cells
Phase 1/2
10/14/2025
8:00 AM
Abstract

Corbus Pharmaceuticals announced today the European Society for Medical Oncology (ESMO) Congress 2025 abstract for its Phase 1/2 clinical study has been released.

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SPRO
Spero Therapeutics Inc
Tebipenem
Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP)
10/14/2025
8:00 AM
Presentation

Spero Therapeutics announces presentations on tebipenem Hbr at the upcoming IDWeek annual meeting to take place Oct 19 – 22, 2025 in Atlanta, GA.

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APRE
Aprea Therapeutics Inc
APR-1051
Next Generation WEE1 Kinase Inhibitor
10/14/2025
8:00 AM
Abstract

Aprea Therapeutics, Inc. y announced that two abstracts on its clinical programs, APR-1051 amd ATRN-119, have been accepted for poster presentation at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 - 26, 2025 at the Hynes Convention Center in Boston, Massachusetts.

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LXRX
Lexicon Pharmaceuticals Inc
pilavapadin
For the treatment of diabetic peripheral neuropathic pain (DPNP)
10/14/2025
8:00 AM
Additional data

Lexicon Pharmaceuticals, Inc. announced the Company presented additional clinical data and program updates from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit.

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CING
Cingulate Inc.
CTx-1301
Attention Deficit/Hyperactivity Disorder (ADHD)
New Drug Application (NDA)
10/14/2025
8:00 AM
review

Cingulate Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company's lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.

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SNGX
Soligenix Inc
HyBryte
In the treatment of cutaneous T-cell lymphoma (CTCL)
Phase 3
10/14/2025
7:33 AM
Guidance

Soligenix, Inc announced today the update of its United States (U.S.) Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL) to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of CTCL, a rare class of non-Hodgkin's lymphoma (NHL).

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MRUS
Merus NV
petosemtamab
For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
10/14/2025
7:30 AM
Interim Data

Merus N.V announced initial interim clinical data as of an April 28, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L, 2L metastatic CRC (mCRC) and petosemtamab monotherapy in 3L+ mCRC.

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NEO
NeoGenomics Inc
RaDaR ST
sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels.
10/14/2025
7:05 AM
Presentation Update

NeoGenomics, Inc announced the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company's circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.

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TNXP
Tonix Pharmaceuticals Holding Corp
TNX-1500
Humanized monoclonal antibody
10/14/2025
7:19 AM
Provided Update

Tonix Pharmaceuticals Holding Corp announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled "The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation," at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan.

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ARMP
Armata Pharmaceuticals Inc
AP-SA02
For complicated Staphylococcus aureus bacteremia.
Phase 2a
10/14/2025
7:00 AM
Late-Breaking Data

Armata Pharmaceuticals, Inc. announced it will be presenting late-breaking Phase 2a clinical data on its Staphylococcus aureus bacteriophage cocktail, AP-SA02, at IDWeek 2025™, which is being held October 19-22, 2025, in Atlanta, GA.

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DTIL
Precision BioSciences Inc
ARCUS
Eliminate DNA of living cells and organisms.
10/14/2025
7:01 AM
Oral presentation

Precision BioSciences, Inc announced that it has been selected to deliver a late-breaking oral presentation at the Liver Meeting® 2025.

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IMAB
I-MAB
Givastomig
In patients with advanced cancers
Phase 1
10/14/2025
7:00 AM
Abstract

I-Mab announced that an abstract related to updated data from the Phase 1 study of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma (GEC) has been accepted as a "short-talk" at the AACR-NCI-EORTC conference which will be held October 22-26 in Boston, Massachusetts.

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TRAW
Traws Pharma Inc
ratutrelvir
An Oral Mpro Inhibitor
Phase 2
10/14/2025
7:00 AM
Dosing Update

Traws Pharma, Inc. announced the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed COVID subjects.

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RCKT
Rocket Pharmaceuticals Inc
KRESLADI
For severe Leukocyte Adhesion Deficiency-I
10/14/2025
7:00 AM
BLA Resubmission

Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), a lentiviral vector (LV)-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I), a rare genetic immune disorder that predisposes patients to recurrent and fatal infections and is near-uniformly fatal in childhood without an allogeneic hematopoietic stem cell transplant.

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MCRB
Seres Therapeutics Inc
SER-155
Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD)
Phase 1b
10/14/2025
7:00 AM
Data

Seres Therapeutics, Inc. announced that new post hoc data from its SER-155 Phase 1b trial will be featured in an oral presentation at IDWeek 2025, taking place October 19–22 in Atlanta, Georgia.

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TNXP
Tonix Pharmaceuticals Holding Corp
TNX-1500
Humanized monoclonal antibody
10/14/2025
7:00 AM
Provided Update

Tonix Pharmaceuticals announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled "The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation," at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan.

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FULC
Fulcrum Therapeutics Inc
FTX-6274
EED, inhibitor, in castration-resistant prostate cancer.
10/14/2025
7:00 AM
Preclinical Data

Fulcrum Therapeutics, nnounced that it will present preclinical data for FTX-6274, an oral embryonic ectoderm development, or EED, inhibitor, in castration-resistant prostate cancer.

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GYRE
Gyre Therapeutics
Hydronidone
Treatment of Liver Fibrosis in Chronic Hepatitis B
Phase 3
10/14/2025
7:00 AM
Results

Gyre Therapeutics announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

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BTAI
BioXcel Therapeutics Inc
BXCL501 (SERENITY)
Schizophrenia and bipolar disorders
10/14/2025
7:00 AM
Positive Results

BioXcel Therapeutics, announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial.

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SGENPFE
Seagen Inc
Pfizer Inc
TUKYSA (Tucatinib)
Metastatic HER2-Positive Breast Cancer
Phase 3
10/14/2025
6:45 AM
Positive Results

Pfizer Inc. announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

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denifanstat
For Liver Diseases
pre-New Drug Application (NDA)
10/14/2025
6:00 AM
Provided Update

Ascletis Pharma Inc. announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon.

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TBPH
Theravance Biopharma Inc
YUPELRI (Revefenacin)
Chronic obstructive pulmonary disease (COPD)
10/14/2025
6:00 AM
Presentation

Theravance Biopharma, Inc. announced that it will be presenting two rapid-fire presentations at CHEST 2025, the annual meeting of the American College of Chest Physicians taking place from October 19-22, 2025, in Chicago, IL.

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ZLAB
Zai Lab Ltd
ZL-1310
For DLL3+ Solid Tumors
10/13/2025
12:07 PM
Late-breaking abstract

Zai Lab Limited announced that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston, Massachusetts.

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ATNM
Actinium Pharmaceuticals Inc
ATNM-400
Prostate Cancer Radiotherapy
10/13/2025
12:14 PM
Preclinical Data

Actinium Pharmaceuticals, Inc. announced that the first-ever preclinical data from its ATNM-400 program in non-small cell lung cancer (NSCLC) has been accepted for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22 – 26, 2025, at the Hynes Convention Center in Boston, Massachusetts.

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NUVL
Nuvalent, Inc.
NVL-330
For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC).
10/13/2025
12:53 PM
Upcoming presentations

Nuvalent, Inc. announced an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston.

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PMVP
PMV Pharmaceuticals Inc
rezatapopt
In patients with advanced solid tumors
10/13/2025
4:01 PM
Abstract Presentation

PMV Pharmaceuticals, Inc. announced that two abstracts have been accepted for oral and poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston, MA.

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ZYME
Zymeworks Inc
ZW191
A Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate
Phase 1
10/13/2025
4:02 PM
Poster Presentation

Zymeworks announced the acceptance of a poster presentation discussing preliminary results from a Phase 1 study evaluating ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-⍺ (FR⍺), at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025, in Boston, MA.

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DNLI
Denali Therapeutics Inc
tividenofusp alfa
Treatment For Hunter Syndrome
Biologics License Applications (BLA)
10/13/2025
4:03 PM
Review Extension

Denali Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

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RPTX
Repare Therapeutics Inc
RP-1664
Oral PLK4 Inhibitor
Phase 1
10/13/2025
4:05 PM
Top-line data

Repare Therapeutics Inc announced it will share initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS trial in a poster presentation at the 37th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, MA.

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BBI-825
In Cancer Patients with Resistance Gene Amplifications
10/13/2025
4:10 PM
Upcoming presentations

Boundless Bio announced an upcoming poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 in Boston, MA.

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ANAB
AnaptysBio Inc
Rosnilimab (formerly ANB030)
Healthy Volunteer
Phase 2b
10/13/2025
9:15 AM
Data Presentation

AnaptysBio, Inc. announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025.

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RNA
Avidity Biosciences Inc
del-zota
for people living with Duchenne Muscular Dystrophy amenable to exon 44 skipping (DMD44).
Pre-BLA Meeting
10/13/2025
9:00 AM
FDA Meeting

Avidity Biosciences, Inc. announced that the Company completed a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming BLA submission of delpacibart zotadirsen (del-zota).

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PALI
Palisade Bio, Inc.
PALI-2108
For patients affected by UC.
10/13/2025
8:49 AM
Provided Update

Palisade Bio, Inc. announced that the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, "Gut Microbiota Bioactivated PDE4 Inhibitor Precursors." The patent covers the composition of PALI-2108, the Company's orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.

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ProSense Cryoablation System
T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer
10/13/2025
8:30 AM
Provided Update

IceCure Medical Ltd. announced its participation at Aptitude Health's TME Take the Lead in Breast Cancer Care Fall Summit 2025, which took place on September 26–27, 2025, in New Orleans, Louisiana.

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ATNM
Actinium Pharmaceuticals Inc
ATNM-400
Prostate Cancer Radiotherapy
10/13/2025
8:30 AM
Preclinical Data

Actinium Pharmaceuticals, announced that compelling preclinical data for ATNM-400, its novel, first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225), has been accepted for presentation at the 32nd Annual Prostate Cancer Foundation (PCF) Scientific Retreat being held on October 23 – 25, 2025 in Carlsbad, CA.

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ANGO
AngioDynamics Inc
NanoKnife System
Treating men with unifocal intermediate-risk prostate cancer
10/13/2025
8:30 AM
Provided Update

AngioDynamics, Inc. announced that its NanoKnife System has been selected as one of TIME's 2025 Best Inventions.

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GILD
Gilead Sciences Inc
Trodelvy (sacituzumab govitecan-hziy)
Metastatic urothelial cancer (UC)
10/13/2025
8:30 AM
Provided Update

Gilead Sciences, Inc and Kite, a Gilead Company, will demonstrate progress in our commitment to transform how cancer is treated with new data at the European Society for Medical Oncology (ESMO) 2025 Congress October 17 – 21.

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CER-1236
For Ovarian Cancer
Phase 1
10/13/2025
8:30 AM
Clinical Trial

CERo Therapeutics Holdings, Inc. announces it has concluded the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML).

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MNKD
MannKind Corp
Afrezza (Technosphere Insulin or TI)
Type 2 (T2D) diabetes
Biologics License Applications (BLA)
10/13/2025
8:05 AM
FDA Accepted

MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes.

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AORT
Artivion, Inc.
AMDS Hybrid Prosthesis
Acute DeBakey Type I Aortic Dissections
10/13/2025
8:00 AM
Data Presentation

Artivion, Inc announced data from its AMDS PERSEVERE and PROTECT trials were presented in Late-Breaking Science presentations at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Copenhagen, Denmark.

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ATOS
Atossa Therapeutics Inc
Z-endoxifen
Breast cancer in the neoadjuvant (prior to surgery) setting
10/13/2025
8:00 AM
Provided Update

Atossa Therapeutics, Inc. announces key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company's lead program across major jurisdictions.

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APYX
Apyx Medical Corp
Renuvion
Contracting subcutaneous soft tissue following liposuction in multiple areas of the body
10/13/2025
8:00 AM
Provided Update

Apyx Medical Corporation announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the label expansion of the AYON Body Contouring System ("AYON") to include power liposuction.

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FDMT
4D Molecular Therapeutics Inc
4D-710
Cystic fibrosis lung disease
10/13/2025
8:00 AM
Provided Update

4D Molecular Therapeutics announced that the Cystic Fibrosis Foundation (CF Foundation) will provide up to $11 million in additional funding, with an initial tranche of $7.5 million, and technical support to accelerate the development of 4D-710 for the treatment of cystic fibrosis (CF) lung disease.

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EVX-01
Metastatic Melanoma
10/13/2025
8:00 AM
Data Presentation

Evaxion A/S will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.

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HCM
HUTCHMED (China) Limited
FRUSICA-2
Advanced Renal Cell Carcinoma
10/13/2025
12:00 AM
Results

HUTCHMED (China) Limited announces results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma.

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IMMPPRRUF
Immutep Ltd
eftilagimod alpha
For cancer and autoimmune disease
10/13/2025
8:00 AM
Positive Feedback

Immutep Limited announces that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti).

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CDTX
Cidara Therapeutics Inc
CD388
Universal Prevention and Treatment of Influenza
Phase 2
10/13/2025
8:00 AM
Late-Breaking Data

Cidara Therapeutics, Inc. announced it will be presenting late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.

VCN-01
Retinoblastoma
10/13/2025
8:00 AM
Upcoming presentations

Theriva™ Biologics announced upcoming presentations at the European Society for Medical Oncology (ESMO 2025) Annual Congress and at Infectious Diseases Week (IDWeek) 2025 Annual Meeting.

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SLS
SELLAS Life Sciences Group Inc
SLS009
For Treatment of Acute Myeloid Leukemia
10/13/2025
8:00 AM
Presentation

SELLAS Life Sciences Group, Inc. announced that preclinical efficacy of its highly selective CDK9 inhibitor, SLS009 (tambiciclib), as a monotherapy and in combination with venetoclax in T-cell prolymphocytic leukemia (T-PLL), will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17 – 21, 2025, in Berlin, Germany.

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BCAX
Bicara Therapeutics Inc
ficerafusp alfa
squamous cancer of the anal canal (SCAC).
Breakthrough Therapy Designation
10/13/2025
7:30 AM
Designation Grant

Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.

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QTORIN™ rapamycin
In the Journal of Vascular Anomalies
10/13/2025
7:30 AM
Provided Update

Palvella Therapeutics, Inc announced it has received the second year of funding under its FDA Office of Orphan Products Development grant.

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ABEO
Abeona Therapeutics Inc
ABO-503
Gene Therapy for X-linked Retinoschisis (XLRS)
Rare Disease Endpoint Advancement (RDEA) Pilot Program.
10/13/2025
7:30 AM
Provided Update

Abeona Therapeutics Inc. announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot Program.

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TVRD
Tvardi Therapeutics Inc
TTI-101
In Idiopathic Pulmonary Fibrosis
Phase 2
10/13/2025
7:30 AM
Provided Update

Tvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).

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BCTBCTX
BriaCell Therapeutics Corp
Bria-IMT
Metastatic breast cancer (breast cancer that has spread beyond the breast)
Phase 3
10/13/2025
7:30 AM
Data Presentation

BriaCell Therapeutics Corp will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.

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ABBV
AbbVie Inc
Temab-A
Advancing Targeted Therapies for Solid Tumors
10/13/2025
7:15 AM
New Data

AbbVie announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany.

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PGEN
Precigen Inc
PAPZIMEOS
For Treatment Of Adults With Recurrent Respiratory Papillomatosis
10/13/2025
7:00 AM
Follow-up data

Precigen, Inc. announced long-term follow-up data demonstrating durable responses to PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

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CGEN
Compugen Ltd
COM701
Solid tumors
10/13/2025
7:00 AM
Analysis

Compugen Ltd. announced that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO).

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ARVN
Arvinas Inc
Vepdegestrant
For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
10/13/2025
7:00 AM
New Data

Arvinas, Inc. announced that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) Congress to be held October 17 through 21, 2025, in Berlin, Germany.

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AZNAZNCF
AstraZeneca PLC
Durvalumab
Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy
10/13/2025
7:00 AM
New Data

AstraZeneca advances its ambition to redefine cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025.

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BMYBMYMP
Bristol-Myers Squibb Company
iza-bren
For Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
10/13/2025
6:59 AM
Data Presentation

Bristol Myers Squibb announced the presentation of data across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2025 to be held from October 17-21 in Berlin, Germany.

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LLYTNGX
Eli Lilly and Co
Tango Therapeutics, Inc.
Verzenio (abemaciclib)
Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
10/13/2025
6:45 AM
New Data

Eli Lilly and Company announced that new data from across its oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting, taking place October 17-21 in Berlin, Germany.

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PFE
Pfizer Inc
ABRYSVO
Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
10/13/2025
6:45 AM
Data Presentation

Pfizer Inc. will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025.

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ONC
BeOne Medicines Ltd
sonrotoclax
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Breakthrough Therapy Designation
10/13/2025
6:00 AM
Designation Grant

BeOne Medicines Ltd y announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

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CGEM
Cullinan Therapeutics Inc
zipalertinib
For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
10/12/2025
6:27 PM
New Data

Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations and CNS involvement.

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MRNA
Moderna Inc
mRNA-4359
Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma
Phase 1/2
10/12/2025
6:05 PM
Safety Data

Moderna, Inc announced that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025, in Berlin, Germany.

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RCUS
Arcus Biosciences Inc
STAR-221
For Metastatic Upper GI Cancers
Phase 2
10/12/2025
6:05 PM
Results

Arcus Biosciences, Inc announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.

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CRSP
CRISPR Therapeutics AG
SyNTase
Gene Editing Technology
10/10/2025
8:00 AM
Preclinical Data

CRISPR Therapeutics today reported new preclinical data from its novel SyNTase™ gene editing platform for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

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ASMB
Assembly Biosciences Inc
ABI-5366
For recurrent genital herpes.
Phase 1b
10/10/2025
8:00 AM
Clinical Data

Assembly Biosciences, Inc announced that interim Phase 1b clinical data for its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-5366 are featured in a late-breaking oral presentation during the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)- Europe, taking place October 9-11, 2025, in Athens, Greece.

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CDTX
Cidara Therapeutics Inc
CD388
Universal Prevention and Treatment of Influenza
10/10/2025
8:00 AM
Late Breaking Presentation

Cidara Therapeutics, Inc announced it will have a late-breaking presentation at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain.

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INSP
Inspire Medical Systems Inc
Inspire V
for patients with obstructive sleep apnea (OSA)
10/10/2025
7:00 AM
Outcome

Inspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers.

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ITCIJNJ
Intra-Cellular Therapies Inc
Johnson & Johnson
CAPLYTA (Lumateperone)
Depressive Episodes associated with Bipolar
10/10/2025
7:30 AM
Abstract Presentation

Johnson & Johnson announced that 17 abstracts featuring new clinical and real-world data will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands.

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AVXL
Anavex Life Sciences Corp
ANAVEX®2-73-AD-EP-004
for the potential treatment of early Alzheimer's disease.
10/10/2025
7:31 AM
Oral presentation

Anavex Life Sciences Corp. announced that Prof. Dr. Timo Grimmer, MD, member of the Anavex Scientific Advisory Board and National Coordinating Investigator for the blarcamesine Phase IIb/III ANAVEX®2-73-AD-004 study gave an oral presentation titled, "Advancing Alzheimer's Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine" at the 35th Alzheimer Europe Conference ‘Connecting Science and Communities

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PLSE
Pulse Biosciences Inc
nPulse™ Cardiac Surgical System
treatment of atrial fibrillation (AF)
10/10/2025
7:00 AM
Results

Pulse Biosciences, Inc. announced late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark.

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OST-HER2
In patients with HER2-expressing solid tumors in breast cancer and other cancers
Phase 2b
10/10/2025
6:00 AM
Survival data

OS Therapies Inc. announced statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Fully Resected Metastatic Osteosarcoma Trial").

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STOK
Stoke Therapeutics Inc
zorevunersen
For the treatment of Dravet syndrome with a confirmed mutation,
10/09/2025
4:30 PM
Presentation

Stoke Therapeutics, Inc and Biogen Inc announced the presentation of longer-term follow-up analyses from the ongoing open-label extension (OLE) studies of zorevunersen that support the potential of zorevunersen as a disease-modifying medicine for Dravet syndrome.

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QNCX
Quince Therapeutics Inc
eDSP
For Treatment Of Rare Neurodegenerative Disease Ataxia-Telangiectasia
10/09/2025
4:05 PM
Poster Presentation

Quince Therapeutics, Inc announced the poster presentation of patient-reported walking capacity in children with Ataxia-Telangiectasia (A-T) at the 54th Child Neurology Society (CNS) Annual Meeting.

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VIR
Vir Biotechnology Inc
VIR-5500
Treatment of Metastatic Prostate Cancer
Phase 1
10/09/2025
4:05 PM
Dose Update

Vir Biotechnology, Inc announced that the first patient has been dosed in Part 3 of the Company's Phase 1 clinical trial evaluating VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs).

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CABA
Cabaletta Bio Inc
CABA-201
For Treatment of Generalized Myasthenia Gravis
10/09/2025
12:00 PM
Initial Data

Cabaletta Bio, Inc. today presented initial dose data from the RESET-PV™ trial evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201) at 1 x 106 cells/kg without preconditioning in three evaluable patients with pemphigus vulgaris (PV).

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EDIT
Editas Medicine Inc
EDIT-401
Gene and Cell Therapy
10/09/2025
11:01 AM
Data

Editas Medicine today reported in vivo preclinical proof-of-concept data for EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (LDL-C), at the 32nd Annual European Society of Gene and Cell Therapy (ESGCT) Congress in Seville, Spain.

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ADIL
Adial Pharmaceuticals Inc
AD04
Alcohol Use Disorder (AUD)
10/09/2025
8:40 AM
Provided Update

Adial Pharmaceuticals, Inc announced the successful completion of the analytical validation of a cheek swab collection method for testing patients for both clinical trial usage as well as future commercial application.

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ABBV
AbbVie Inc
BOTOX (onabotulinumtoxinA)
Upper Limb Spasticity
10/09/2025
8:00 AM
Provided Update

Allergan Aesthetics, an AbbVie company announced the rollout of SkinMedica®'s reimagined packaging—a modernized look that elevates the consumer experience while advancing sustainability.

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ATXS
Astria Therapeutics, Inc.
Navenibart
For the Treatment of Hereditary Angioedema
10/09/2025
8:00 AM
Poster Presentation

Astria Therapeutics, Inc. announced that it will present two posters at the Canadian Society of Allergy and Clinical Immunology (CSACI) 80th Anniversary Scientific Meeting, taking place October 15-18, 2025 in Vancouver, British Columbia.

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TACTI-004
In Non-Small Cell Lung Cancer
Phase 3
10/09/2025
8:00 AM
Enrollment Update

Immutep Limited announces a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC).

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MIST
Milestone Pharmaceuticals Inc
Etripamil
For Treatment in Paroxysmal Supraventricular Tachycardia
10/09/2025
8:00 AM
Poster Presentation

Milestone® Pharmaceuticals Inc. announced that it will present a poster presentation at the American Heart Association Scientific Sessions 2025, to be held November 7-10th in New Orleans, Louisiana.

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OBIO
Orchestra BioMed Holdings Inc
Atrioventricular Interval Modulation ("AVIM") Therapy
in the management of hypertensive heart disease
10/09/2025
8:00 AM
Data Presentation

Orchestra BioMed Holdings, announced a data summary supporting the transformative potential of Atrioventricular Interval Modulation ("AVIM") Therapy in the management of hypertensive heart disease will be presented in a keynote talk at the Georgia Innovation Summit in Tbilisi, Georgia on October 10, 2025.

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TSHA
Taysha Gene Therapies Inc
TSHA-102
Rett Syndrome
Phase 1/2
10/09/2025
8:00 AM
Results

Taysha Gene Therapies, Inc. announced results from a new supplemental data analysis from Part A of the REVEAL Phase 1/2 adult/adolescent and pediatric trials evaluating TSHA-102 in females with Rett syndrome at the 54th Child Neurology Society (CNS) Annual Meeting.

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CDTX
Cidara Therapeutics Inc
CD388
Universal Prevention and Treatment of Influenza
Breakthrough Therapy Designation
10/09/2025
8:00 AM
Designation Grant

Cidara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.

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ACXP
Acurx Pharmaceuticals, Inc.
ACX-375C
DNA Polymerase IIIC Inhibitors
10/09/2025
7:30 AM
Provided Update

Acurx Pharmaceuticals, Inc. announced that a new patent has been granted by the Australian Patent Office.

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OST-HER2
In patients with HER2-expressing solid tumors in breast cancer and other cancers
10/09/2025
7:40 AM
Regulatory Update

OS Therapies Inc. announced a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB).

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ANVS
Annovis Bio Inc
Buntanetap
Parkinson's Disease (PD)
10/09/2025
7:30 AM
Results

Annovis Bio, Inc announced new results that demonstrate buntanetap's ability to attenuate inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond symptomatic relief.

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ALRN
Aileron Therapeutics Inc
LTI-03
In Idiopathic Pulmonary Fibrosis
European Medicines Agency (EMA)
10/09/2025
7:30 AM
Authorization

Rein Therapeutics announced that it has received authorization from the European Medicines Agency (EMA) to initiate the Company's Phase 2 "RENEW" clinical trial of its lead candidate, LTI-03, for the treatment of idiopathic pulmonary fibrosis (IPF).

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ATHEPRNAF
Alterity Therapeutics Ltd
ATH434
To inhibit the aggregation of pathological proteins implicated in neurodegeneration
Phase 2
10/09/2025
7:25 AM
Data

Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) was featured at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) that took place in Honolulu, HI, USA.

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B-FREE
for Chronic Babesiosis Treatment
10/09/2025
7:18 AM
Study Initiation

60 Degrees Pharmaceuticals, Inc announced today the name of its chronic babesiosis trial is the B-FREE Chronic Babesiosis Study.

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TNXP
Tonix Pharmaceuticals Holding Corp
TNX-801
Potential Vaccine to Prevent Mpox and Smallpox
10/09/2025
7:00 AM
Provided Update

Tonix Pharmaceuticals announced that Dr. Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research, will present and Dr. Bavari and Dr. Zeil Rosenberg, M.D., Executive Vice President, Medical will participate in a panel discussion at the World Vaccine Congress–Europe 2025, taking place October 14–16, 2025, in Amsterdam, the Netherlands. Details on both sessions are provided below.

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ABBVRGNX
AbbVie Inc
Regenxbio Inc
ABBV-RGX-314
In patients with wet AMD
Phase 2
10/09/2025
7:05 AM
Data Presentation

REGENXBIO Inc. announced that it will present interim data from the Phase II ALTITUDE® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy of Ophthalmology 2025 Annual Meeting.

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LGND
Ligand Pharmaceuticals Inc
Lasix® ONYU
Home Treatment for Edema in Heart Failure Patients
10/09/2025
7:00 AM
FDA Approval

Ligand Pharmaceuticals nnounced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure.

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GHRS
GH Research PLC
GH001
Resistant Depression
Phase 2b
10/09/2025
7:00 AM
Presentation

GH Research PLC announced the acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 – 14, where Professor Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201).

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NGN-401
For Rett Syndrome
10/09/2025
7:00 AM
Dosing Update

Neurogene Inc announced plans to initiate dosing in the fourth quarter of 2025

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NGN-401
For Rett Syndrome
10/09/2025
7:00 AM
Provided Update

Neurogene Inc. announced the Company has completed discussions with the U.S. Food and Drug Administration (FDA) on its Embolden™ registrational trial protocol

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MRK
Merck & Co Inc
Doravirine/Islatravir
In adults with HIV-1 infection
10/09/2025
7:00 AM
Findings Update

Merck announced today that it will present new findings from its HIV treatment and prevention pipeline at the 20th European AIDS Conference (EACS 2025) taking place Oct.15-18, 2025, in Paris, France.

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GANX
Gain Therapeutics, Inc.
GT-02287
GBA1 Parkinson's disease
10/09/2025
7:00 AM
Provided Update

Gain Therapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event, "Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287" featuring Key Opinion Leaders (KOLs), Karl Kieburtz, M.D., M.P.H., Professor of Neurology, University of Rochester and Kenneth Marek, M.D., President and Senior Scientist, Institute for Neurodegenerative Disorders.

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BDX
BD (Becton, Dickinson and Company)
XTRACT™
Peripheral Artery Disease
10/09/2025
6:53 AM
Enrollment Update

BD (Becton, Dickinson and Company) announced the enrollment of the first patient in the XTRACT™ Registry, a prospective, multi-center, single-arm, post-market registry study designed to evaluate the real-world performance of the Rotarex™ Catheter System in the treatment of patients with peripheral artery disease (PAD) lesions.

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MRK
Merck & Co Inc
KEYTRUDA®(pembrolizumab)
For the treatment of patients with locally advanced or metastatic urothelial carcinoma
10/09/2025
6:45 AM
Provided Update

Merck announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company's broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17-21.

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GLSI
Greenwich LifeSciences Inc
GLSI-100
Breast cancer recurrences
10/09/2025
6:00 AM
Expansion

Greenwich LifeSciences, Inc. announced the expansion of FLAMINGO-01 clinical trial to Austria.

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GTBP
GT Biopharma Inc
GTB-3650
For Treatment of CD33+ Leukemia
Phase 1
10/08/2025
9:00 AM
Enrollment Update

GT Biopharma announced that enrollment in the dose escalation cohorts of the Phase 1 trial, evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies, is well on track.

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REGNSNYSNYNF
Regeneron Pharmaceuticals Inc
Sanofi SA
Libtayo (Cemiplimab-Rwlc)
Advanced Non-Small Cell Lung Cancer (NSCLC) with PD-L1
10/08/2025
2:31 PM
Approved

Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

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RIGL
Rigel Pharmaceuticals Inc
R289
For Lower-Risk MDS
Phase 1b
10/08/2025
9:34 AM
Enrollment Update

Rigel Pharmaceuticals, Inc nnounced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study of R2891 in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS).

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ATXS
Astria Therapeutics, Inc.
Navenibart
For the Treatment of Hereditary Angioedema
Phase 3
10/08/2025
9:33 AM
Initiation

Astria Therapeutics, Inc. announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE).

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HOWL
Werewolf Therapeutics, Inc.
WTX-124
Solid Tumors
Fast Track Designation
10/08/2025
9:32 AM
Designation Grant

Werewolf Therapeutics, Inc. announced that the Company has received Fast Track Designation for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy.

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AARD
Aardvark Therapeutic Inc
ARD-101
for Prader-Willi Syndrome
10/08/2025
9:30 AM
Provided Update

Aardvark Therapeutics, Inc announces alignment with the U.S. Food and Drug Administration (FDA) on a protocol amendment to the company's Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS).

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TRVI
Trevi Therapeutics Inc
nalbuphine ER
chronic cough in patients with idiopathic pulmonary fibrosis (IPF)
10/08/2025
9:29 AM
Abstract Presentation

Trevi Therapeutics, announced the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting, to be held from October 19 to 22 in Chicago, Illinois.

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ABEO
Abeona Therapeutics Inc
ZEVASKYN
To Treat Wounds in Painful Skin Disorder
10/08/2025
9:26 AM
Provided Update

Abeona Therapeutics Inc announced activation of Children's Colorado as the newest Qualified Treatment Center (QTC) for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets.

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MDT
Medtronic PLC
Hugo
for gynecological procedures
10/08/2025
7:10 AM
Clinical Study

Medtronic plc announced the start of the Embrace Gynecology investigational device exemption (IDE) U.S. clinical study to evaluate the safety and effectiveness of its Hugo™ robotic-assisted surgery (RAS) system in robotic-assisted gynecological procedures.

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neflamapimod
In patients with dementia with Lewy bodies (DLB)
Phase 2b
10/08/2025
7:00 AM
Additional data

CervoMed Inc announced additional data from its Phase 2b RewinD-LB trial, further demonstrating neflamapimod's potential as a treatment for dementia with Lewy bodies (DLB).

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AQST
Aquestive Therapeutics Inc
Anaphylm
For epinephrine prodrug candidate product
10/08/2025
7:00 AM
Provided Update

Aquestive Therapeutics, Inc announced the United States Patent and Trademark Office (USPTO) has issued two additional U.S. patents related to Anaphylm, the Company's novel epinephrine prodrug sublingual film.

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IMRN
Immuron Ltd
IMM-529
Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection
Investigational New Drug (IND)
10/08/2025
6:00 AM
IND Submission

Immuron Limited announce that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for clinical development of IMM-529.

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CLPT
ClearPoint Neuro Inc
ClearPoint Prism Neuro Laser Therapy System
Brain Tumor Laser Therapy
Phase 1/2
10/07/2025
4:15 PM
Results

ClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy..

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IMMX
Immix Biopharma, Inc.
NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
10/07/2025
4:10 AM
Presentation

Immix Biopharma, Inc announced that it will present a NXC-201 abstract at the upcoming American Society of Hematology (ASH) 67th Annual Meeting and Exposition to be held December 6-9, 2025, in Orlando, Florida.

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VRCA
Verrica Pharmaceuticals Inc
VP-315
For the Treatment of Basal Cell Carcinoma
10/07/2025
4:05 PM
Presentation

Verrica Pharmaceuticals announced that it will be presenting both an oral presentation and a poster on VP-315, its oncolytic peptide for the treatment of basal cell carcinoma (BCC), at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland.

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AZNAZNCF
AstraZeneca PLC
Bax24
Patients with treatment-resistant hypertension (rHTN)
10/07/2025
5:23 AM
Results

AstraZeneca announced Positive high-level results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared with placebo at 12 weeks. Efficacy was observed throughout the 24-hour period, including early morning, when patients with hypertension are at a higher risk of cardiovascular events.

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CTXR
Citius Pharmaceuticals Inc
LYMPHIR
For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
10/07/2025
9:17 AM
Provided Update

Citius Oncology, Inc. announced it is actively engaging with regional distribution partners to make LYMPHIR™ (denileukin diftitox-cxdl) available to eligible patients through country-specific Named Patient Programs (NPPs) in Europe, South America and the Middle East.

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AEMD
Aethlon Medical Inc
Hemopurifier
Severe COVID-19
10/07/2025
8:01 AM
Provided Update

Aethlon Medical, Inc today provided observations on the preliminary changes in extracellular vesicle (EV), microRNA and lymphocyte counts in the first patient cohort in its ongoing oncology clinical trial in Australia.

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JNJ
Johnson & Johnson
Icotrokinra
For adults and adolescents with plaque psoriasis
Phase 2b
10/07/2025
8:10 AM
Results

Johnson & Johnson announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).

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JNJ
Johnson & Johnson
Guselkumab
For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Phase 3
10/07/2025
8:05 AM
New Data

Johnson & Johnson announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC).

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JNJ
Johnson & Johnson
ACUVUE OASYS MAX 1-Day
for Astigmatism
10/07/2025
8:00 AM
New Data

Johnson & Johnson announced new data on the ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses which showed higher end-of-day comfort^ as compared to Dailies Total1® for Astigmatism.

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COCH
Envoy Medical® Inc
Acclaim
for Breakthrough Hearing Device
10/07/2025
8:00 AM
FDA approved

Envoy Medical, announced that it received approval from the U.S. Food and Drug Administration (FDA) to expand the Company's pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage based on promising three-month data from the first 10 patients.

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INVA
Innoviva Inc
Zoliflodacin
For the Treatment of Uncomplicated Gonorrhea
10/07/2025
8:00 AM
Data

Innoviva, Inc. announced that it will deliver data from six presentations at IDWeek 2025, including clinical data, pharmacokinetic-pharmacodynamic (PK-PD) analyses, and microbiologic surveillance from its growing portfolio of antibiotics and critical care medicines. IDWeek will be held in Atlanta, GA, from October 19-22, 2025.

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GALT
Galectin Therapeutics Inc
Belapectin (Formerly GR-MD-02)
Non-alcoholic steatohepatitis (NASH) with cirrhosis
10/07/2025
8:00 AM
Provided Update

Galectin Therapeutics announced participation in the AASLD Liver Meeting 2025.

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ABUS
Arbutus Biopharma Corp
AB-101
Oral PD-L1 inhibitor
10/07/2025
8:00 AM
Abstract

Arbutus Biopharma announced that three abstracts featuring imdusiran data and one abstract featuring AB-101 data, have been accepted for poster presentations at the American Association for the Study of Liver Diseases ("AASLD") – The Liver Meeting 2025, taking place November 7–11 in Washington, DC. Notably, the AB-101 abstract has been selected as a Poster of Distinction.

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AVIR
Atea Pharmaceuticals Inc
Bemnifosbuvir
COVID-19
10/07/2025
8:00 AM
New Data

Atea Pharmaceuticals, Inc. announced that new data will be presented supporting the combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, as a potential best-in-class regimen for the treatment of hepatitis C (HCV) infection at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

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JNJ
Johnson & Johnson
apalutamide
For the treatment of prostate cancer (nmCRPC)
10/07/2025
8:00 AM
Presentation

Kairos Pharma, Ltd. announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress.

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KAPA
Kairos Pharma Ltd
carotuximab
in advanced, castration-resistant prostate cancer
10/07/2025
8:00 AM
Presentation

Kairos Pharma, Ltd. announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress.

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Telomir-1
Potential treatment for age-related conditions
10/07/2025
7:30 AM
Results

Telomir Pharmaceuticals, Inc announced new preclinical results showing that its investigational therapy Telomir-1 reactivated two of the body's most important tumor suppressor genes, MASPIN ("tumor suppressor shield") and RASSF1A ("guardian gene"; also called SERPINB5), through DNA methylation reset in prostate cancer models.

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SNGX
Soligenix Inc
HyBryte
In the treatment of cutaneous T-cell lymphoma (CTCL)
10/07/2025
7:30 AM
Data Safety Monitoring Board (DSMB) Meeting

Soligenix, Inc. announced that its first Data Monitoring Committee (DMC) meeting for its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies.

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ARWR
Arrowhead Pharmaceuticals Inc
ARO-DIMER-PA
for the Treatment of Mixed Hyperlipidemia
10/07/2025
7:30 AM
Provided Update

Arrowhead Pharmaceuticals, Inc. announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-DIMER-PA, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia.

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NVAX
Novavax Inc
Nuvaxovid
Covid-19
10/07/2025
7:00 AM
Provided Update

Novavax, Inc. announced that it has completed the transfer of the marketing authorization for its COVID-19 vaccine, Nuvaxovid® to Sanofi, in the European Union (EU) enabling Sanofi to take full responsibility for commercial and regulatory activities in the EU.

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PLSE
Pulse Biosciences Inc
nPulse™ Cardiac Surgical System
treatment of atrial fibrillation (AF)
10/07/2025
7:00 AM
Upcoming presentations

Pulse Biosciences, Inc. announced the upcoming presentation of early clinical data on the treatment of atrial fibrillation (AF) using the nPulse™ Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting from October 8-11th in Copenhagen, Denmark.

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denifanstat
For Liver Diseases
Phase 2b
10/07/2025
7:00 AM
Analysis

Sagimet Biosciences Inc. announced that analyses of the Phase 2b FASCINATE-2 study showing that denifanstat elicited fibrosis improvement in patients with advanced fibrosis will be presented at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025, taking place November 7-11, 2025 in Washington, DC.

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Rejuva
For the treatment of obesity and type 2 diabetes (T2D),
10/07/2025
7:00 AM
Preclinical Data

Fractyl Health, Inc. announced potent new preclinical data from RJVA-002, the second candidate from the Company's Rejuva® Smart GLP-1™ platform, at the 2025 Cell & Gene Meeting on the Mesa.

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ENTA
Enanta Pharmaceuticals Inc
zelicapavir
For respiratory syncytial virus
10/07/2025
7:05 AM
Data

Enanta Pharmaceuticals, Inc announced that data for zelicapavir, its oral, once-daily, N-protein inhibitor will be presented at IDWeek™ 2025 being held October 19 - 22, 2025 virtually and at the Georgia World Congress Center in Atlanta, Georgia.

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ENTA
Enanta Pharmaceuticals Inc
EDP-323
Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B
10/07/2025
7:00 AM
Data

Enanta Pharmaceuticals, Inc announced that data for EDP-323, it's oral, once-daily L-protein inhibitor, both in development for the treatment of respiratory syncytial virus (RSV), will be presented at IDWeek™ 2025 being held October 19 - 22, 2025 virtually and at the Georgia World Congress Center in Atlanta, Georgia.

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AKRO
Akero Therapeutics Inc
Efruxifermin
Non-alcoholic steatohepatitis (NASH)
10/07/2025
7:00 AM
Upcoming presentations

Akero Therapeutics, Inc. announced two upcoming oral presentations and a poster presentation at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 taking place November 7-11, 2025, in Washington, DC.

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LLY
Eli Lilly and Co
mirikizumab-mrkz
For Crohn's disease
10/07/2025
6:45 AM
New Data

New data from Eli Lilly and Company showed Omvoh (mirikizumab-mrkz) is the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active ulcerative colitis (UC) achieve sustained, long-term outcomes through four years.

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ACET
Adicet Bio Inc
ADI-001
B cell non-Hodgkin's lymphoma (NHL)
10/07/2025
6:45 AM
Efficacy and Safety Data

Adicet Bio, Inc announced initial safety and efficacy data from the first seven patients dosed with ADI-001 in the ongoing Phase 1 study evaluating ADI-001 as a potential treatment for patients with autoimmune diseases.

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LX2006
For the Treatment of Friedreich's Ataxia Cardiomyopathy
Phase 1/2
10/07/2025
6:00 AM
Provided Update

Lexeo Therapeutics, Inc announced updates to key components of an Accelerated Approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy, alongside new interim clinical data from ongoing Phase I/II studies.

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DYN
Dyne Therapeutics Inc
DYNE-101
Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus
Phase 1/2
10/06/2025
6:01 PM
Additional data

Dyne Therapeutics, Inc. announced additional one-year data from its ongoing Phase 1/2 ACHIEVE clinical trial of zeleciment basivarsen (z-basivarsen, formerly known as DYNE-101), in patients with myotonic dystrophy type 1 (DM1) demonstrating clinically meaningful improvements in function and strength at the selected registrational dose.

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BIIB
Biogen Inc
LEQEMBI® (lecanemab-irmb)
Treatment of Alzheimer's Disease
10/06/2025
4:30 PM
Provided Update

Eisai Co., Ltd. and Biogen Inc. announced that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).

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Telomir-1
Potential treatment for age-related conditions
10/06/2025
4:06 PM
New Data

Telomir Pharmaceuticals Announces New Findings in a Prostate Cancer Model Demonstrating Telomir-1 Also Resets DNA Methylation of Tumor Suppressor Genes Implicated in Two of the Most Persistent Challenges in Oncology—Metastasis and Treatment Resistance

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BMEA
Biomea Fusion, Inc.
icovamenib
For 2 diabetes
10/06/2025
4:03 PM
Results

Biomea Fusion, Inc. announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D).

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KALV
KalVista Pharmaceuticals Inc
sebetralstat
Therapy for hereditary angioedema (HAE).
10/06/2025
4:00 PM
New Data

KalVista Pharmaceuticals, Inc announced new data from its KONFIDENT and KONFIDENT-S studies of EKTERLY® (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE), presented at the 20th German Allergy Congress in Düsseldorf, Germany from October 2–4, 2025.

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NRSN
NeuroSense Therapeutics Ltd
PrimeC
Amyotrophic lateral sclerosis
10/06/2025
9:07 AM
Findings Update

NeuroSense Therapeutics Ltd. announced new positive findings based on plasma samples from its Phase-2b PARADIGM study.

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ABBV
AbbVie Inc
BOTOX (onabotulinumtoxinA)
Upper Limb Spasticity
Phase 2
10/06/2025
9:00 AM
Top-line results

AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor.

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RNA
Avidity Biosciences Inc
EXPLORE44
in People Living with DMD44
10/06/2025
9:00 AM
Oral presentation

Avidity Biosciences, Inc. announced that it will deliver late-breaking oral and poster presentations at the 30th Annual International Congress of the World Muscle Society (WMS), to be held October 7-11, 2025, in Vienna, Austria.

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JAGX
Jaguar Health Inc
Crofelemer
Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Type C Meeting
10/06/2025
9:00 AM
Provided Update

Jaguar Health, today provided its assessment of the company's Type C Meeting with the U.S. Food and Drug Administration (FDA) on October 2, 2025 to seek their advice for efficient advancement of the company's clinical trial of its novel crofelemer powder formulation for oral solution for the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board, including a key opinion leader who is the principial investigator for the ongoing open-label investigator-initiated trial (IIT) in the UAE, along with its other advisors, participated in this meeting.

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EDIT
Editas Medicine Inc
EDIT-401
Gene and Cell Therapy
10/06/2025
9:00 AM
Oral presentation

Editas Medicine, Inc. announced an oral presentation at the upcoming European Society of Gene and Cell Therapy (ESGCT) Congress, to be held October 7-10, 2025, in Seville, Spain.

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ARQT
Arcutis Biotherapeutics Inc
ZORYVE™ (roflumilast)
Inhibitor of phosphodiesterase-4 (PDE4)
supplemental New Drug Application (sNDA)
10/06/2025
8:00 AM
FDA approved

Arcutis Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.

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ACOGF
Alpha Cognition Inc.
ZUNVEYL
For the Treatment of Mild to Moderate Alzheimer's Disease
10/06/2025
8:34 AM
Presentation

Alpha Cognition Inc announced it will present new clinical insights on cholinesterase inhibitors and ZUNVEYL® (Benzgalantamine) at the American Society of Consultant Pharmacists (ASCP) Annual Meeting, October 23–25, 2025.

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NBIX
Neurocrine Biosciences Inc
INGREZZA (Valbenazine)
Tardive Dyskinesia
10/06/2025
8:30 AM
Data

Neurocrine Biosciences, Inc. today presented new data from the open-label KINECT®-HD2 study demonstrating an established long-term safety profile, tolerability and sustained improvements in chorea severity through three years of treatment with once-daily INGREZZA® (valbenazine) capsules in adults with Huntington's disease.

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HUMA
Humacyte, Inc.
Human Acellular Vessel
Coronary Artery Bypass Grafting
10/06/2025
8:00 AM
Publication

Humacyte, Inc. announced the publication in Oxford Academic's Military Medicine of positive long-term results from its humanitarian program using Symvess to treat wartime vascular trauma injuries in Ukraine.

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PLRZ
Polyrizon Ltd
PL-14
For seasonal allergic rhinitis.
10/06/2025
8:21 AM
Results

Polyrizon Ltd. announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation.

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GANX
Gain Therapeutics, Inc.
GT-02287
GBA1 Parkinson's disease
10/06/2025
8:15 AM
Poster Presentation

Gain Therapeutics, Inc. today presented a poster at the International Congress of Parkinson's Disease and Movement Disorders® summarizing early safety and tolerability findings, the primary endpoint, and observations from key exploratory endpoints from the Phase 1b clinical study of GT-02287 in people with Parkinson's disease (PD) with or without a GBA1 mutation.

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ATOS
Atossa Therapeutics Inc
Z-endoxifen
Breast cancer in the neoadjuvant (prior to surgery) setting
Phase 2
10/06/2025
8:00 AM
Provided Update

Atossa Therapeutics, Inc. (announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer.

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RCUS
Arcus Biosciences Inc
ARC-20
In patients that had received both prior TKI and anti-PD-1 therapy.
10/06/2025
8:00 AM
Data

Arcus Biosciences, Inc announced new monotherapy data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in late-line metastatic clear cell renal cell carcinoma (ccRCC).

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VCN-12
to treat cancer and related diseases
10/06/2025
8:00 AM
Upcoming presentations

Theriva™ Biologics announced an upcoming presentation at the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), to be held in Seville, Spain from 7-10 October 2025.

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SPRB
Spruce Biosciences Inc
TA-ERT
for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).
Breakthrough Therapy Designation
10/06/2025
8:00 AM
Designation Grant

Spruce Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

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CNTX
Context Therapeutics Inc
CT-95
For mesothelin-expressing cancers.
10/06/2025
7:30 AM
Poster Presentation

Context Therapeutics Inc. announced two posters will be presented at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, being held November 7–9, 2025, at the Gaylord National Resort and Convention Center in National Harbor, MD.

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RGNX
Regenxbio Inc
surabgene lomparvovec
for Wet AMD
10/06/2025
7:05 AM
Enrollment Update

REGENXBIO Inc. nnounced the completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal studies evaluating surabgene lomparvovec (sura-vec, ABBV-RGX-314) in wet age-related macular degeneration (wet AMD) using subretinal delivery.

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CDNA
CareDx Inc
AlloSeq HCT
Chimerism testing kit for Hematopoietic Cell Transplantation
10/06/2025
7:05 AM
Provided Update

CareDx, Inc. announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida.

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XCUR
Exicure Inc
burixafor
In Multiple Myeloma
10/06/2025
7:04 AM
Provided Update

Exicure's ongoing Phase 2 study (NCT05561751) is a randomized, open-label, multicenter trial evaluating burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant (ASCT) for multiple myeloma.

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VYD2311
Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of PEMGARDA™
Investigational New Drug (IND)
10/06/2025
7:01 AM
FDA Clearance

Invivyd, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody candidate for the prevention of COVID.

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SKYE
Skye Bioscience, Inc.
CBeyond
for obesity and other metabolic health disorders
Phase 2a
10/06/2025
7:00 AM
Top-line data

Skye Bioscience, Inc. announced the topline data from its 26-week Phase 2a CBeyond™ proof-of-concept study of nimacimab, its peripherally-restricted CB1 inhibitor antibody.

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TNGX
Tango Therapeutics, Inc.
TNG260
Immunotherapy of Cancer
10/06/2025
7:00 AM
Poster Presentation

Tango Therapeutics, Inc. announced that the company will have three poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025, including the first clinical data on the novel CoREST inhibitor TNG260 in non-small cell lung cancer. SITC will be held November 5-9, 2025 in National Harbor, Maryland.

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CLRB
Cellectar Biosciences Inc
Iopofosine I-131
Pediatric Brain and Solid Tumors
European Commission Conditional Marketing Authorization
10/06/2025
7:00 AM
Marketing authorization

Cellectar Biosciences announced that after a scientific advice procedure, the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA.

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LYRA
Lyra Therapeutics Inc
LYR-210
Chronic Rhinosinusitis
Phase 3
10/06/2025
7:00 AM
Upcoming presentations

Lyra Therapeutics, Inc. announced the Company's clinical plan and upcoming oral presentation of results from the positive Phase 3 ENLIGHTEN 2 trial for LYR-210, the company's lead product candidate for CRS.

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MRK
Merck & Co Inc
MK-7240
In Inflammatory Bowel Disease
Phase 2b
10/06/2025
6:45 AM
Study Initiation

Merck announced it has initiated three Phase 2b trials evaluating the safety and efficacy of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in patients with three immune-mediated inflammatory diseases

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CXRXF
Advanz Pharma Corp Ltd
AVT23
a proposed biosimilar to Xolair® (omalizumab).
10/06/2025
4:40 AM
Marketing authorization

Advanz Pharma Holdco Limited announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab).

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obefazimod
for the treatment of moderate-to-severely active ulcerative colitis
10/06/2025
4:10 AM
Additional data

Abivax SA announced additional clinical data for obefazimod were delivered in a second late-breaking presentation at the United European Gastroenterology (UEG) Meeting in Berlin, Germany.

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Privosegtor
For Vision Loss
10/06/2025
4:10 AM
Provided Update

Oculis Holding AG announces the advancement of Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the U.S. Food and Drug Administration (FDA).

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AZNAZNCF
AstraZeneca PLC
Datopotamab deruxtecan (Dato-DXd)
Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
10/06/2025
3:24 AM
Positive Results

AstraZeneca and Daiichi Sankyo announced Positive high-level results from the TROPION-Breast02 Phase III trial showed Datroway (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.

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ARVN
Arvinas Inc
ARV-102
PROTAC® degrader designed to target the LRRK2 protein
Phase 1
10/05/2025
2:00 PM
Positive Data

Arvinas, Inc. announced positive pharmacokinetic, pharmacodynamic, and biomarker data from two Phase 1 clinical trials evaluating ARV-102, an oral, brain-penetrant investigational PROTAC degrader of leucine-rich repeat kinase 2 (LRRK2).

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obefazimod
for the treatment of moderate-to-severely active ulcerative colitis
10/05/2025
11:00 AM
Results

Abivax SA announced results from the first of two late-breaking presentations at the United European Gastroenterology (UEG) Meeting in Berlin, Germany.

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SPY002
For enhanced potency to both TL1A monomers and trimers
10/05/2025
9:00 AM
Presentation

Spyre Therapeutics, Inc. announced scientific presentations at the UEGW Congress.

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ProSense Cryoablation System
T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer
10/03/2025
12:22 PM
Marketing authorization

IceCure Medical Ltd. announced that the U.S. Food and Drug Administration ("FDA") has granted marketing authorization to IceCure's De Novo application for the ProSense® cryoablation system for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy, representing approximately 46,000 women annually in the U.S.

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OVID
Ovid Therapeutics Inc
OV329
In Treatment-Resistant Seizures
Phase 1
10/03/2025
10:47 AM
Top-line results

Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) activity of OV329, a next generation GABA-aminotransferase (GABA-AT) inhibitor being developed for drug-resistant epilepsies.

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SSKN
Strata Skin Sciences Inc
XTRAC 308nm
Laser Treatment Combined with a Topical Drug in Psoriasis
10/03/2025
10:50 AM
Highlights

STRATA Skin Sciences, Inc highlights the substantial body of peer-reviewed clinical evidence supporting the XTRAC® Excimer Laser (308 nm) as a safe, highly effective treatment for localized atopic dermatitis, the most common form of eczema.

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CADL
Candel Therapeutics, Inc.
CAN-2409
Prostate cancer
10/03/2025
9:05 AM
Presentation

Candel Therapeutics, Inc. announced the Company will present insights from its enLIGHTEN™ Discovery Platform, and additional data from the CAN-2409 (aglatimagene besadenovec) program in non-small cell lung cancer (NSCLC), through two accepted poster presentations at the Society for Immunotherapy of Cancer's (SITC) 40th Anniversary Annual Meeting, taking place November 5-9, 2025 in National Harbor, Maryland.

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CHRS
Coherus BioSciences Inc
CHS-114
In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
10/03/2025
9:05 AM
Upcoming presentations

Coherus Oncology announced an upcoming poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 5-9, 2025, in National Harbor, Maryland.

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ALXO
ALX Oncology Holdings Inc
ASPEN-06
In Patients With HER2-Positive Gastric Cancer
10/03/2025
9:05 AM
Updated data

ALX Oncology Holdings Inc nnounced updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will be presented during a poster session at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland.

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EVX-01
Metastatic Melanoma
10/03/2025
9:00 AM
New Data

Evaxion A/S will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025.

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HOWL
Werewolf Therapeutics, Inc.
WTX-124
Solid Tumors
10/03/2025
9:00 AM
Poster Presentation

Werewolf Therapeutics, Inc announced that three posters will be presented at the upcoming Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, taking place November 5-9, 2025, in National Harbor, Maryland.

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BCAB
BioAtla Inc
BA3011 (Mecbotamab Vedotin)
Solid Tumors
10/03/2025
9:00 AM
Clinical Data

BioAtla, Inc. announced that clinical data for its investigational AXL-targeting antibody-drug conjugate (ADC), mecbotamab vedotin (BA3011), will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting to be held at National Harbor, MD from November 5-9, 2025.

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XLO
Xilio Therapeutics, Inc.
XTX301
Solid tumors
10/03/2025
9:00 AM
Poster Presentation

Xilio Therapeutics, Inc. announced multiple upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 6-9, 2025 at the Gaylord National Convention Center in National Harbor, Maryland.

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SRPT
Sarepta Therapeutics Inc
ELEVIDYS (delandistrogene moxeparvovec-rokl)
Designed to address the underlying cause of Duchenne muscular dystrophy through the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.
10/03/2025
8:30 AM
Presentation

Sarepta Therapeutics, Inc will present at the 30th Annual Congress of the World Muscle Society (WMS) 2025 Congress, taking place Oct. 7-11, 2025, in Vienna, Austria.

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ESPR
Esperion Therapeutics Inc
NEXLETOL
treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
10/03/2025
8:00 AM
Provided Update

Esperion announced that it has entered into a settlement agreement with Dr. Reddy's Laboratories, Inc. and its affiliate Dr. Reddy's Laboratories Ltd. (together, Dr. Reddy's Laboratories).

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ALTO-101
For Schizophrenia
Fast Track Designation
10/03/2025
7:34 AM
Designation Grant

Alto Neuroscience, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS).

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BCTBCTX
BriaCell Therapeutics Corp
Bria-OTS
In metastatic breast cancer
10/03/2025
7:30 AM
Presentation

BriaCell Therapeutics Corp. is pleased to announce that the Company will be presenting preclinical Bria-OTS+ data at a poster presentation at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, held November 7-9, 2025, in National Harbor, MD.

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OVID
Ovid Therapeutics Inc
OV329
In Treatment-Resistant Seizures
Phase 1
10/03/2025
7:00 AM
Top-line results

Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) activity of OV329, a next generation GABA-aminotransferase (GABA-AT) inhibitor being developed for drug-resistant epilepsies.

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MEOBFMESO
Mesoblast Ltd
RYONCIL
For the treatment of severe and life-threatening inflammatory conditions.
10/02/2025
9:04 PM
Provided Update

Mesoblast Limited announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025.1

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CDTX
Cidara Therapeutics Inc
CD388
Universal Prevention and Treatment of Influenza
10/02/2025
4:01 PM
Provided Update

Cidara Therapeutics, Inc. announced it has received an award valued up to $339M from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

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SVRA
Savara Inc
Molgramostim (IMPALA-2)
Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
10/02/2025
4:05 PM
Poster Presentation

Savara Inc. announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22.

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JAZZ
Jazz Pharmaceuticals PLC
Zepzelca (lurbinectedin)
Relapsed Small Cell Lung Cancer (SCLC)
10/02/2025
3:35 PM
FDA approved

Jazz Pharmaceuticals announced that the Food and Drug Administration approved lurbinectedin

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ACAD
ACADIA Pharmaceuticals Inc
ACP-711
GABRA3 modulators
10/02/2025
9:04 AM
Late Breaking Presentation

Acadia Pharmaceuticals Inc announced one late-breaker oral platform presentation and two poster presentations to be presented at the International Congress of Parkinson's Disease and Movement Disorders® being held October 5-9, 2025, in Honolulu, Hawaii.

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AMGN
Amgen Inc
Repatha (Evolocumab)
HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events
Phase 3
10/02/2025
9:00 AM
Endpoint Met

Amgen announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke.

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EB-003
In treat mental health disorders
10/02/2025
8:45 AM
Provided Update

Enveric Biosciences announced significant progress in the chemistry, manufacturing, and controls (CMC) development of its lead candidate, EB-003.

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SSII
SS Innovations International Inc
SSi Mantra surgical robotic system
robotic surgery
10/02/2025
8:30 AM
Provided Update

SS Innovations International announced that the Company successfully completed a human factors validation study for its SSi Mantra surgical robotic system (the "SSi Mantra") at Johns Hopkins Hospital in September 2025

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KZIA
Kazia Therapeutics Limited
Paxalisib
Atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer
10/02/2025
8:30 AM
Provided Update

Kazia Therapeutics Limited today reported a substantial reduction in tumor burden from a single-patient expanded access case in triple-negative breast cancer (TNBC) treated with a combination regimen that included the Company's investigational pan-PI3K/mTOR inhibitor, paxalisib.

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EWTX
Edgewise Therapeutics, Inc
sevasemten
For Becker muscular dystrophy
10/02/2025
8:00 AM
Provided Update

Edgewise Therapeutics, Inc., announced its participation at the 30th International Annual Congress of the World Muscle Society (WMS).

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ECUR-506
For the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency
10/02/2025
8:00 AM
Additional data

iECURE, Inc announced that additional data from the ongoingOTC-HOPE clinical trial evaluating its candidate ECUR-506 in neonatal onset ornithine transcarbamylase (OTC) deficiency will be presented at the European Society of Gene & Cell Therapy (ESGCT) Annual Congress, taking place October 7-10, 2025 in Sevilla, Spain and the American Society of Human Genetics (ASHG) Annual Meeting, taking place October 14-18 in Boston.

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SNYSNYNFRVTY
Sanofi SA
Revvity Inc
T1D 4-plex
diabetic ketoacidosis (DKA)
10/02/2025
8:12 AM
Provided Update

Revvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.

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HOLX
Hologic Inc
Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.
Detect Common Causes of Infectious Gastroenteritis
10/02/2025
8:05 AM
FDA Clearance

Hologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.

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URGN
UroGen Pharma Ltd
ZUSDURI
for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
10/02/2025
8:00 AM
Publication

UroGen Pharma Ltd. announced the publication of a comprehensive review of the clinical development program for ZUSDURI™ (mitomycin) for intravesical solution, formerly known as UGN-102, the first and only FDA-approved medicine for adults with recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC).

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TSHA
Taysha Gene Therapies Inc
TSHA-102
Rett Syndrome
Breakthrough Therapy Designation
10/02/2025
8:00 AM
Designation Grant

Taysha Gene Therapies, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TSHA-102, an intrathecally delivered AAV9 gene therapy with disease modifying potential, for the treatment of Rett syndrome.

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ATXS
Astria Therapeutics, Inc.
Navenibart
For the Treatment of Hereditary Angioedema
Phase 3
10/02/2025
8:00 AM
Clinical Trial

Astria Therapeutics, Inc announced that it has begun opening clinical trial sites in the European Union (EU) and may begin screening participants for the Phase 3 ALPHA-ORBIT trial of navenibart, an investigational monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of hereditary angioedema (HAE) with the potential for dosing every 3 and 6 months.

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DNTH103
In Generalized Myasthenia Gravis (gMG)
Phase 2
10/02/2025
8:00 AM
Results

Dianthus Therapeutics, Inc announced that the results of the Phase 2 MaGic trial of claseprubart in generalized Myasthenia Gravis (gMG) will be presented in an oral presentation at the American Association of Neuromuscular and Electromagnetic Medicine (AANEM) Annual Meeting, taking place October 29 to November 1, 2025 in San Francisco, California. In addition, the Company will host a virtual industry forum on October 29 titled Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition.

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ATHEPRNAF
Alterity Therapeutics Ltd
ATH434-201
Investigation of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its progression.
10/02/2025
7:35 AM
Data

Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) will be featured at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) taking place October 5-9, 2025 in Honolulu, HI, USA.

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AVXL
Anavex Life Sciences Corp
ANAVEX®3-71
For the treatment of neurodegenerative and neurodevelopmental disorders
Phase 2
10/02/2025
7:30 AM
Top-line results

Anavex Life Sciences Corp. announced positive topline results from its placebo-controlled Phase 2 clinical study evaluating ANAVEX®3-71 for the treatment of schizophrenia in adults on stable antipsychotic medication (ANAVEX3-71-SZ-001, NCT06245213).

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PGN-EDODM1
For Myotonic Dystrophy Type 1 (DM1)
10/02/2025
7:00 AM
Oral presentation

PepGen Inc announced that the Company's data will be presented in two oral presentations at the 30th Annual International Congress of the World Muscle Society (WMS) being held October 7-12, 2025, in Vienna, Austria. One of the presentations will include previously reported positive FREEDOM-DM1 Phase 1 clinical data.

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PSV359
Patients with FAP-α Positive Solid Tumors
Phase 1/2a
10/02/2025
7:00 AM
Provided Update

Perspective Therapeutics, announced that the first patient was treated with [212Pb]PSV359 in a second cohort of the Company's Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α). Patients are being selected for [212Pb]PSV359 targeted alpha particle therapy by SPECT imaging with [203Pb]PSV359.

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IMRN
Immuron Ltd
Travelan
To prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
10/02/2025
6:08 AM
Provided Update

Immuron Limited is pleased to provide shareholders with a brief update on progress with a number of projects.

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RADX
Radiopharm Theranostics
RAD202
to treat HER2-positive advanced and metastatic cancers
10/01/2025
8:00 AM
Recommendation

Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 ‘HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. T

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BOLT
Bolt Biotherapeutics, Inc
BDC-4182
patients with gastric and gastroesophageal cancer.
Phase 1
10/01/2025
4:05 PM
Dose escalation

Bolt Biotherapeutics announced an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody™ ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology.

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MBOT
Microbot Medical Inc
LIBERTY® Endovascular Robotic Surgical System
Device Study
10/01/2025
9:14 AM
Provided Update

Microbot Medical announced that the Japanese Patent Office has granted the Company its first patent in Japan, covering the core LIBERTY® System technology, such as a compact robotic device for driving and manipulating movement of at least one elongate surgical tool. Inc.

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CDXC
ChromaDex Corp
Niagen
Nicotinamide Riboside Chloride or NRC
10/01/2025
8:32 AM
Provided Update

Niagen Bioscience, Inc announces that pharmaceutical-grade Niagen Plus™ products, Niagen IV and injections, are now offered at more than 50 iCRYO locations across the U.S., bringing availability to more than 900 clinics nationwide.

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AVHHLRCEL
AVITA Medical Inc
RECELL System
Extensive Burns and Pediatric Patients
10/01/2025
8:30 AM
Provided Update

AVITA Medical®, Inc. announced that beginning October 1, 2025, hospitals across the U.S. will be eligible for New Technology Add-on Payment (NTAP) reimbursement from the Centers for Medicare & Medicaid Services (CMS) when RECELL is used to treat acute, non-burn trauma and surgical full-thickness wounds.

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ASBP
Aspire Biopharma Holdings Inc
Sublingual Aspirin
Diabetes, Weight Management
10/01/2025
8:30 AM
Provided Update

Aspire Biopharma Holdings, announced pipeline progress and key milestones expected through the remainder of 2025 and early 2026. The company is focusing its pipeline on reformulating approved drugs for multi-billion-dollar markets by utilizing its disruptive, patent-pending sublingual delivery technology.

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CRSP
CRISPR Therapeutics AG
SyNTase
Gene Editing Technology
10/01/2025
8:00 AM
Presentation

CRISPR Therapeutics To Present Preclinical Data On Alpha-1 Antitrypsin Deficiency Utilizing Novel SyNTase Gene Editing Technology

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SLDB
Solid Biosciences Inc
SGT-003
For Duchenne Muscular Dystrophy Gene Therapy
10/01/2025
8:00 AM
Presentation

Solid Biosciences Inc. will present data from its neuromuscular and cardiac programs at the World Muscle Society (WMS) 2025 Annual International Congress, October 7-11, 2025, in Vienna, Austria, and at the European Society of Gene & Cell Therapy (ESGCT) 2025 Annual Congress, October 7-12, 2025, in Seville, Spain.

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CAMP
CAMP4 Therapeutics Corporation
CMP-SYNGAP-01
Treatment rescued multiple SYNGAP1-dependent behavioral phenotypes
10/01/2025
8:00 AM
Study Initiation

CAMP4 Therapeutics announced the initiation of toxicology studies conducted under Good Laboratory Practice (GLP) standards for its lead product candidate, CMP-SYNGAP-01.

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FBIOFBIOP
Fortress Biotech Inc
CUTX-101
Menkes disease
10/01/2025
8:00 AM
Complete Response Letter

Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration ("FDA") has issued a Complete Response Letter ("CRL") relating to the New Drug Application ("NDA") for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.

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MLTX
MoonLake Immunotherapeutics AG
Sonelokimab
Moderate-to-severe hidradenitis suppurativa
10/01/2025
8:12 AM
Provided Update

MoonLake Immunotherapeutics nnounced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or "HS").

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ADGM
Adagio Medical Holdings Inc
FULCRUM-VT
for Ventricular Tachycardia
10/01/2025
8:00 AM
Enrollment Update

Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company's vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT).

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ALNY
Alnylam Pharmaceuticals Inc
Zilebesiran (ALN-AGT)
Mild-to-Moderate Hypertension
Phase 3
10/01/2025
7:30 AM
Dosing Update

Alnylam Pharmaceuticals, Inc announced that the first patient has been dosed in ZENITH (ZilebEsiraN CardIovascular OuTcome Study in Hypertension), a global Phase 3 cardiovascular outcomes trial (CVOT) designed to evaluate the potential of zilebesiran, an investigational biannual subcutaneously administered RNAi therapeutic, to reduce the risk of major adverse cardiovascular (CV) events in patients with uncontrolled hypertension.

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KURA
Kura Oncology Inc
KOMET-007
Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
10/01/2025
7:01 AM
Dose Update

Kura Oncology, Inc and Kyowa Kirin Co., Ltd. announced dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184).

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AZNAZNCF
AstraZeneca PLC
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
For the treatment of adult patients with unresectable or metastatic HER2 positive
Biologics License Applications (BLA)
10/01/2025
7:00 AM
FDA Accepted

Daiichi Sankyo and AstraZeneca announced that the supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer.

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ARVN
Arvinas Inc
ARV-102
PROTAC® degrader designed to target the LRRK2 protein
10/01/2025
7:00 AM
Presentation

Arvinas, Inc. announced that two presentations, including one e-poster session and one oral platform presentation, featuring clinical data for ARV-102, an investigational oral PROTAC (PROteolysis TArgeting Chimera) degrader of leucine-rich repeat kinase 2 (LRRK2), will be presented at the 2025 International Congress of Parkinson's Disease and Movement Disorders® (MDS 2025) being held October 5–9, 2025, in Honolulu.

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BMYBMYMP
Bristol-Myers Squibb Company
BMS-986446
Treatment of Alzheimer's Disease
Fast Track Designation
10/01/2025
6:59 AM
Designation Grant

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development for the treatment of early Alzheimer's disease.

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denifanstat
For Liver Diseases
Phase 1
10/01/2025
7:00 AM
Dose Update

Sagimet Biosciences Inc. announced that the Company has dosed the first participants in a Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom.

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PHARPHGUF
Pharming Group
Leniolisib
Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)
supplemental New Drug Application (sNDA)
10/01/2025
1:00 AM
FDA Accepted

Pharming Group N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.

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What is an FDA Calendar?

Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.

Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.

The calendar lists down all key catalysts that can materially impact stocks, including:

  • PDUFA dates, or in other words FDA decision dates
  • Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
  • FDA decisions (approvals/complete response letter/delay)
  • According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
  • FDA’s Advisory Committee, or Adcom, meetings
  • Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
  • Decisions by overseas regulatory agencies
  • Clinical data readouts
  • Presentation of data at various scientific conferences.

The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development. 

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes. 

Biotech Stock Movers

Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.

A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.

Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.

PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.

Stock Movers

Gainers

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Loser

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Frequently Asked Questions

Q

What is an FDA PDUFA date?

A

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.

PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.

A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.

The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.

Q

How long does an FDA approval take?

A

A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.

Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.

Q

How do you find FDA approvals?

A

A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.