FDA Calendar

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.

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.

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.

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.

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.

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.

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).

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).

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

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.

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:

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.

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.

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.

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.

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).

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.

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.

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.

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

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.

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.

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.

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

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.

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).

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

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).

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).

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.

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

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

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

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

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.

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).

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.

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.

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.

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

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).

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).

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.

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.

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

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

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.

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

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.

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.

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.

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").

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.

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.

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.

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.

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..

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.

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

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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).

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

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

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

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..

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

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

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.

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.

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.

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).

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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).

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

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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

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.

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).

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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

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.

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

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.

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.

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).

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).

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.

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.

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.

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.

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

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).

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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").

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.

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.

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).

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).

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.

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.

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

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.

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).

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.

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.

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.

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.

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

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).

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.

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).

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.

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

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.

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.

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.

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).

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

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

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.

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.

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.

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.

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

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.

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.

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).

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

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.

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).

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.

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

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.

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).

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.

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.

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..

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

Galectin Therapeutics announced participation in the AASLD Liver Meeting 2025.

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.

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).

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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

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).

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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).

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.

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).

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.

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).

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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.

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.

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

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).

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.

Jazz Pharmaceuticals announced that the Food and Drug Administration approved lurbinectedin