FDA Calendar

AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease.

Fractyl Health, Inc. announced groundbreaking results from the REMAIN-1 Midpoint Cohort, supporting the potential for Revita to be the first therapy to preserve weight loss after GLP-1 drug discontinuation.

Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza® (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).

KalVista Pharmaceuticals, Inc announced the acceptance of six abstracts for ePoster presentation at the 20th German Allergy Congress taking place in Düsseldorf, Germany from October 2–4, 2025.

Mesoblast Limited today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products.

Eli Lilly and Company announced today that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.

Crinetics Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) approved PALSONIFYTM (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

Kura Oncology, announced the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML).

Organogenesis Holdings announced that the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA), did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial.

Zimmer Biomet Holdings announced the Pharmaceutical and Medical Devices Agency (PMDA) in Japan approved the iTaperloc® Complete and iG7™ Hip System, the world's first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.

Quince Therapeutics, Inc. announced the publication of an advanced population pharmacokinetic (PK) modeling study of pediatric patients with Ataxia-Telangiectasia (A-T) and healthy adults treated with its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient's own red blood cells), in the scientific journal CPT: Pharmacometrics & Systems Pharmacology (PSP).

Cidara Therapeutics, Inc announced that the first participants have been dosed in its Phase 3 trial to evaluate the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications of influenza.

Sanofi SA announced that The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Genzyme Corporation (now Sanofi).

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

Intellia Therapeutics, announced longer-term follow-up data from the ongoing Phase 1 study of investigational nexiguran ziclumeran (nex-z) for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN).

Jaguar Health, Inc. announced that it has received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of a $250,000 grant. Canalevia, under the name Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs.

Tiziana Life Sciences, Ltd announces it will advance its second asset, a fully human anti-IL-6 receptor ("IL-6R") monoclonal antibody, TZLS-501.

Clene Inc announced the presentation of the combined REPAIR-MS results across relapsing MS and non-active progressive MS during the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held September 24-26, 2025, in Barcelona, Spain.

Vanda Pharmaceuticals Inc. announced the publication of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial" in PLOS One, a leading open-access journal.1

Rallybio Corporation announced the completion of dosing of the first cohort in the Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) study evaluating RLYB116, the Company's innovative, once-weekly, small volume, subcutaneously injected C5 inhibitor.

Vertex Pharmaceuticals Incorporated announced several important advancements across its programs in immunoglobulin A Nephropathy (IgAN), APOL1-mediated kidney disease (AMKD) and autosomal dominant polycystic kidney disease (ADPKD).

Anebulo Pharmaceuticals, Inc announces the first subjects dosed in its Phase 1 single ascending dose ("SAD") study of intravenous (IV) selonabant in healthy young adults. The study is supported by a collaborative grant from the National Institute on Drug Abuse (NIDA).

MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns.

Capricor Therapeutics announced a regulatory update for its Biologics License Application (BLA) for Deramiocel, the Company's investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD).

Leap Therapeutics, Inc announced it will present the final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.

AC Immune SA announced the peer-reviewed publication in eBioMedicine of results from the completed Phase 1b/2a trial of active immunotherapy ACI-35.030's (JNJ-2056) partnered with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company.

Bristol Myers Squibb announced an expansion of its direct-to-patient offerings, providing eligible U.S. patients with steeply discounted prices for Eliquis® (apixaban) and Sotyktu® (deucravacitinib). Eligible cash-pay patients can now purchase these medicines directly from BMS and significantly lower their out-of-pocket costs.

Pfizer Inc will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer's core scientific modalities and key tumor areas.

Immunic, Inc announced the presentation of key data in an oral and four poster presentations, including one late-breaking poster, at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26, 2025 in Barcelona, Spain.

Aclarion, Inc., announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.

Kyverna Therapeutics, announced updated data from Phase 1 investigator-initiated trials (IITs) of KYV-101 in the treatment of progressive multiple sclerosis (MS) to be presented at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, taking place in Barcelona, Spain from September 24-26, 2025.

IGC Pharma, Inc. announced preclinical findings on TGR-63, the Company's investigational small-molecule candidate for Alzheimer's disease.

Jaguar Health announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an orphan drug designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel prescription drug, for the treatment of diarrhea in adult patients with breast cancer that has metastasized to the brain receiving targeted therapy with or without standard chemotherapy.

Akari Therapeutics announced key preclinical data demonstrating the potential of its novel antibody drug conjugate (ADC) spliceosome modulating payload, PH1, for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer.

Cellectar Biosciences, Inc. have entered into an agreement whereby Evestia will provide Cellectar with full CRO services for their upcoming Phase 1b study evaluating CLR 125 for the treatment of triple-negative breast cancer (TNBC).

Harmony Biosciences Holdings, Inc announced topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS). The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate.

NRx Pharmaceuticals, announced that it was notified yesterday by the United States Food and Drug Administration that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™).

Envoy Medical® Inc announced it is scaling its commercialization planning for the company's breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum.

MAIA Biotechnology, Inc. announced today that the National Institutes of Health (NIH) has awarded a $2.3 million grant for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC).

Eisai Co. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4* non-carriers or heterozygous carriers.

Summit Therapeutics Inc announced that data from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be featured as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) which takes place from October 17–21, 2025, in Berlin, Germany.

Acadia Pharmaceuticals Inc. announced top-line results from the Phase 3 COMPASS PWS trial evaluating the efficacy and safety of intranasal carbetocin (ACP-101) in patients with hyperphagia in Prader-Willi syndrome (PWS).

FibroGen, announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer (mCRPC).

Cidara Therapeutics, Inc. announced updates to its planned Phase 3 registrational trial of CD388 following its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). Cidara is proceeding with an expanded and accelerated development plan seeking biologics license application (BLA) approval based on a single Phase 3 study.

Palvella Therapeutics, Inc. announced the expansion of its QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) development program into Clinically Significant Angiokeratomas.

Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca's capivasertib has received Manufacturing and Marketing Approval from Japan's Ministry of Health, Labour and Welfare (MHLW).

AstraZeneca and Daiichi Sankyo announced that supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

Cybin Inc. today highlights significant clinical and regulatory milestones and upcoming value-driving catalysts as the Company advances multiple programs towards potential commercialization.

Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company's supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA).

Abivax SA announced the presentation of a late breaking abstract for its lead drug candidate, obefazimod, for the treatment of moderately to severely active ulcerative colitis (UC) at The United European Gastroenterology Congress, taking place October 4-7, 2025, in Berlin, Germany.

GRAIL, Inc will present new data highlighting the Galleri® multi-cancer early detection (MCED) test performance and safety from its registrational PATHFINDER 2 study at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Oct. 17-21, 2025.

Neurocrine Biosciences, announced new data from a post-hoc analysis of the Phase 4 KINECT-PRO™ open-label study confirming that robust rates of symptomatic remission of tardive dyskinesia were achieved with once-daily INGREZZA® (valbenazine) capsules.

Veru Inc announced a successful meeting with FDA providing regulatory clarity for enobosarm, a selective androgen receptor modulator, as a muscle preservation drug product candidate in combination with GLP-1 RA for greater weight loss for the treatment of obesity.

Tevogen today highlights emerging scientific evidence linking persistent viral reservoirs to Long COVID, and emphasizes the potential of its investigational precision T cell therapy, TVGN 489, for the treatment of this debilitating condition which affects an estimated 20 million Americans and represents an area of unmet need.

SeaStar Medical Holding Corporation announced today that preliminary results from the SAVE Surveillance Registry will be presented by SeaStar Medical and its research collaborators at the 5th International Symposium on Acute Kidney Injury in Children.

IO Biotech announces a late-breaking abstract has been accepted and selected as a Proffered Paper oral presentation at the 2025 European Society for Medical Oncology (ESMO) Congress taking place in Berlin, Germany from October 17-21, 2025.

Amneal Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL).

Sensei Biotherapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event on Monday, October 20, 2025 at 8:00 AM ET featuring company leadership and Kyriakos Papadopoulos, MD (Co-Director of Clinical Research at START, San Antonio), who will discuss the unmet need and current treatment landscape for immunotherapy-resistant solid tumors.

Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE® (COVID-19 Vaccine, mRNA),which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the apitegromab Biologics License Application (BLA) for the treatment of patients with spinal muscular atrophy (SMA).

atai Life Sciences announced positive data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003 (intranasal mebufotenin benzoate), in patients with treatment-resistant depression (TRD).

Seres Therapeutics, announced receipt of additional constructive feedback from the U.S. Food and Drug Administration (FDA) on the Phase 2 study protocol for the Company's lead program, SER-155, for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT).

Bristol Myers Squibb announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD™), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint.

Elanco Animal Health nnounced important updates to the U.S. Zenrelia label, following the Food and Drug Administration (FDA) review of supplemental scientific data.

Allergan Aesthetics, an AbbVie company announced the roll-out of SKINVIVE by JUVÉDERM® in 35 additional markets this year bringing the total to 57 globally in 2025. This expansion underscores Allergan Aesthetics' global strategic commitment to enhancing skin quality worldwide.

Sanofi announced that The US Food and Drug Administration (FDA) has granted fast track designation to SAR446268, Sanofi's one-time AAV gene therapy for the treatment of non-congenital (juvenile and adult onset) DM1 myotonic dystrophy type 1 (DM1).

GSK plc confirmed today that it will submit a supplemental New Drug Application (sNDA) for Wellcovorin (leucovorin) to update the label to include an indication for the treatment of cerebral folate deficiency (CFD), a rare disorder.

Delcath Systems, Inc announced the acceptance of an oral presentation on results from the investigator-initiated CHOPIN randomized Phase 2 trial at the 2025 European Society for Medical Oncology (ESMO) Annual Congress.

Lexicon Pharmaceuticals, Inc. announced an update to the previous submission of additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D).

Corcept Therapeutics Incorporated will present new data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting.

CERo Therapeutics Holdings, Inc announced that it has dosed the third patient in the starting dose cohort of its Phase 1 clinical trial evaluating CER-1236 in acute myeloid leukemia (AML).

Celcuity Inc. announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025.

IGC Pharma, Inc. announced it has reached a key enrollment milestone of 50% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.

Actuate Therapeutics, Inc. announced a corporate update on the regulatory path for elraglusib in pancreatic cancer and anticipated milestones

Neurocrine Biosciences, announced the presentation of new data from the Phase 2 SAVITRI™ study, which showed statistically significant and clinically meaningful improvement in depression severity at Day 28 and Day 56 with once-daily oral administration of 1 mg osavampator (NBI-1065845).

IceCure Medical announced its participation at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting on September 13-17, 2025, in Barcelona, Spain.

CRISPR Therapeutics announced that the first patient has been dosed in a Phase 2 clinical trial of SRSD107, a next-generation, long-acting Factor XI (FXI) siRNA for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA). SRSD107 is being co-developed by CRISPR Therapeutics and Sirius Therapeutics as part of a strategic collaboration to advance innovative treatments for cardiovascular and clotting-related diseases.

Achieve Life Sciences, Inc. announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD).

Immutep Limited announces the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer.

Anixa Biosciences, Inc announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.

IMUNON, Inc. announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on the Company's proprietary TheraPlas® technology platform, for the treatment of newly diagnosed advanced ovarian cancer. Results were highlighted in a presentation at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research held in Denver, Colorado.

Allarity Therapeutics, Inc. presented new and updated clinical data from the ongoing Phase 2 clinical trial in advanced ovarian cancer patients at the American Association for Cancer Research (AACR) 7th Biennial Special Conference on Ovarian Cancer, held September 19–21, 2025, at the Grand Hyatt Denver in Denver, Colorado.

MIRA Pharmaceuticals, Inc announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of its lead oral candidate, Ketamir-2, in healthy volunteers.

Adverum Biotechnologies, Inc announced it has notified sites that it plans to complete screening in ARTEMIS, its first pivotal Phase 3 trial evaluating Ixo-vec in wet age-related macular degeneration (wet AMD) by September 30, seven months after initiation, because the company now expects full enrollment of at least 284 treatment-naïve and treatment experienced patients in 4Q 2025 and data readout in 1Q 2027.

MediciNova, Inc announced the successful completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Grace Therapeutics, Inc. announced that results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada September 18-21, 2025.

Coya Therapeutics, announced today the launch of the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999).

BioCardia®, Inc. , announces it has had a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Heart Failure Trial results previously provided to the agency.

Jazz Pharmaceuticals plc announced new real-world evidence and Phase 4 data reinforcing the value of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution treatment outcomes in adults with narcolepsy or idiopathic hypersomnia (IH) were presented at World Sleep 2025, held in Singapore from September 5-10, 2025, as well as the 38th annual Psych Congress, held in San Diego from September 17-21, 2025.

Gossamer Bio, Inc announced that five scientific presentations related to seralutinib will be presented at the European Respiratory Society (ERS) Congress 2025, which takes place from September 27th through October 1st in Amsterdam, Netherlands and online. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.

Intellia Therapeutics, announced that longer-term data from the ongoing Phase 1 trial of investigational nex-z for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) will be presented at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors, taking place September 25-26 in Baveno, Italy.

BridgeBio Pharma, Inc. announced today that one late breaking clinical trials oral presentation, one oral presentation, and three poster sessions will be shared at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2025, taking place in Minneapolis, MN from September 26 - 29, 2025.

Insmed Incorporated announced that it will present seven abstracts from across its late-stage portfolio at the European Respiratory Society (ERS) 2025 Congress, taking place September 27 – October 1, 2025, in Amsterdam.

Exact Sciences Corp. a leading provider of cancer screening and diagnostic tests, is teaming up with actor and horror icon Matthew Lillard to encourage people 45 and older to get screened for colorectal cancer—the nation's second leading cause of cancer-related death.1

Ionis Pharmaceuticals, Inc announced positive topline results from the pivotal study of zilganersen in children and adults living with Alexander disease (AxD), a rare, progressive and often fatal neurological condition with no approved disease-modifying treatments.

MBX Biosciences, Inc. announced once-weekly canvuparatide achieved the primary endpoint with statistical significance at Week 12 in its Phase 2 Avail™ trial, and demonstrated positive 6-month results from the OLE, in adult patients with chronic hypoparathyroidism (HP). All patients (n=64) completed the 12-week study, and 94% of patients elected to enroll in the OLE.

Oculis Holding AG announced the upcoming presentation of the positive Phase 2 ACUITY trial results investigating Privosegtor (OCS-05) in acute optic neuritis at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Congress.

Alvotech announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech's proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd announced the presentation of data from a real-world survey of patients taking AUSTEDO XR® (deutetrabenazine) extended-release tablets. Patients taking AUSTEDO XR reported increased social and emotional well-being as a result of movement reduction, and high overall satisfaction with AUSTEDO XR.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the presentation of 10 posters from its innovative schizophrenia medicines portfolio, including long-term safety data from the completed SOLARIS Phase 3 trial showing no incidence of post-injection delirium/sedation syndrome (PDSS) in study participants taking olanzapine LAI (TEV-'749), a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine.1

C4 Therapeutics, Inc. today presented data from the Phase 1 clinical trial of cemsidomide, an orally bioavailable IKZF1/3 degrader, in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM).

Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™(pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA®(pembrolizumab).

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

GENFIT announced its decision to discontinue its VS-01 program in ACLF (Acute-on-Chronic Liver Failure), and reprioritize the development of VS-01 on UCD (Urea Cycle Disorder).

MBX Biosciences, Inc. announced that it will provide topline results from its Phase 2 clinical trial of potential once-weekly canvuparatide for patients with chronic hypoparathyroidism (HP) and host an investor webcast on Monday, September 22.

Johnson & Johnson announced that an investigational immune-based induction regimen with TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical efficacy in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM).

Polyrizon Ltd announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies.

Verrica Pharmaceuticals Inc. announced that its development partner, Torii Pharmaceutical Co. Ltd. ("Torii") has received approval from the Japanese Ministry of Health, Labour and Welfare ("MHLW") for YCANTH® (TO-208) for the treatment of Molluscum Contagiosum ("molluscum"). Torii became a wholly-owned subsidiary of Shionogi & Co., Ltd., on September 1, 2025.

IMUNON, Inc. announced that new translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research, being held September 19-21, 2025, in Denver, Colorado.

United Therapeutics Corporation announced today that it will host a webcast to review data from the successful TETON-2 pivotal study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) on Sunday, September 28, 2025, at 12:30 p.m. Eastern Time.

Nuvation Bio Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved IBTROZITM (taletrectinib) for the treatment of adult patients with ROS1-positive (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC).

SAB Biotherapeutics, Inc. today highlighted multiple presentations made at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) held from September 15-19, 2025.

Ionis Pharmaceuticals, Inc announced that TRYNGOLZA® (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). .

Skye Bioscience, Inc. announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.

KalVista Pharmaceuticals, Inc announced that the European Commission (EC) and Swiss Agency for Therapeutic Products, Swissmedic, have approved EKTERLY® (sebetralstat), a novel, oral plasma kallikrein inhibitor, for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Syndax Pharmaceuticals announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation (mNPM1).1

Merck announced that announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA® (pembrolizumab), which if approved would be marketed in the European Union (EU) as KEYTRUDA SC™.

Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of ENFLONSIA™ (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season.

Incyte y announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.

PDS Biotechnology announced details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial.

Nektar Therapeutics announced new data from the ongoing REZOLVE-AD Phase 2b study of rezpegaldesleukin, an IL-2 pathway agonist and regulatory T-cell (Treg) proliferator, at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.

Vertex Pharmaceuticals announced today a reimbursement agreement with the Italian Medicines Agency (AIFA) for eligible transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY® (exagamglogene autotemcel).

Grace Therapeutics, Inc announced that the U.S. Patent and Trademark Office has issued a U.S. Patent No. 12,414,943, titled "Nimodipine Parenteral Administration".

NKGen Biotech, Inc. announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 3rd China Great Bay Cell and Gene Therapy Forum, taking place in Guangzhou, China, September 25-26, 2025.

Kairos Pharma, Ltd announces positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Contineum Therapeutics, Inc announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial.

Lipella Pharmaceuticals Inc. announced positive final results from its completed Phase 2a multicenter, dose-ranging study evaluating LP-10, a proprietary liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus (OLP).

Tonix Pharmaceuticals announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD).

Zevra Therapeutics, Inc announced an upcoming oral presentation at the International Niemann-Pick Disease Alliance (INPDA) Face-to-Face Meeting and several poster presentations at the Child Neurology Society (CNS) Annual Meeting, which will be reviewing clinical data on MIPLYFFA® (MY-PLY-FAH) (arimoclomol) for the treatment of Niemann-Pick disease type C (NPC) and OLPRUVA® (sodium phenylbutyrate) for the treatment of certain patients living with urea cycle disorders (UCDs).

Phio Pharmaceuticals Corp announced that Phio Pharmaceuticals is a presenting company at the Life Sciences Future Conference to be held September 25 - 26, 2025.

Intellia Therapeutics, announced it has completed enrollment in the global Phase 3 HAELO study of lonvoguran ziclumeran (lonvo-z) for the treatment of hereditary angioedema (HAE).

Gain Therapeutics, Inc. announced the start of the Phase 1b extension study allowing participants to continue treatment for an additional nine months. More than half of the participants have agreed to continue treatment.

Trevi Therapeutics, announced that data from the Phase 2a RIVER trial of nalbuphine ER for the treatment of patients with RCC, will be highlighted in two poster presentations at the European Respiratory Society (ERS) Congress 2025.

Astrazeneca announced that The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to as-needed albuterol,2 the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% confidence interval [CI]: 0.40, 0.72; p<0.001) when compared with albuterol in adult patients with mild asthma.2

Greenwich LifeSciences, In announced the expansion of FLAMINGO-01 clinical trial to Ireland.

Eli Lilly and Company announced detailed results from SURPASS-PEDS, the first Phase 3 trial to evaluate the safety and efficacy of Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, in children and adolescents (ages 10 to less than 18) with type 2 diabetes inadequately controlled with metformin, basal insulin or both.

Biogen Inc. announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth.

Vor Bio announced that 48-week clinical data from the Phase 3 study in China evaluating telitacicept in adults with generalized myasthenia gravis, a study sponsored by Vor's collaborator RemeGen Co., Ltd will be presented as an oral presentation at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting, being held October 29 to November 1, 2025, at the Hilton San Francisco Union Square in San Francisco, California.

NANOBIOTIX announced new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for patients with advanced cancers.

Regeneron Pharmaceuticals, Inc announced updated analyses from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity.

Eli Lilly and Company announced positive topline results from ACHIEVE-3, an open-label randomized Phase 3 clinical trial evaluating the safety and efficacy of orforglipron compared to oral semaglutide, administered according to approved label instructions, in 1,698 adults with type 2 diabetes inadequately controlled with metformin.

Palisade Bio, Inc. announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor.

J&J Announces Data From Phase 3 ICONIC-ADVANCE 1 And 2 Studies Showing Icotrokinra Demonstrated Superior Skin Clearance vs Deucravacitinib

Candel Therapeutics, Inc. announced that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA.

Cidara Therapeutics, Inc. announced two presentations during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP).

Enveric Biosciences announced the publication of two peer-reviewed research papers describing innovative bioproduction strategies for creating therapeutic compounds.

Elicio Therapeutics, nnounced immunogenicity testing data showing that approximately 99% of evaluable patients (89 of 90) enrolled in its ongoing Phase 2 AMPLIFY-7P trial who were administered ELI-002 7P generated strong mKRAS-specific T cell responses, with an average increase of 145.3x over baseline responses, consistent with observations from prior Phase 1 trials of ELI-002.

Astria Therapeutics, Inc announced positive initial results from the Phase 1a trial of STAR-0310, a YTE half-life extended monoclonal antibody antagonist of OX40, in healthy subjects.

Protagonist Therapeutics, Inc. announced new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies which assessed the superiority of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis.

Rein Therapeutics announced the publication of novel data on its lead drug candidate, LTI-03, in iScience, a peer-reviewed, open-access journal published by Cell Press.

Vyome Holdings, Inc presented results from its preclinical studies investigating VT-1908 (the first topical formulation of mycophenolate) for treating uveitis at the recent Annual Meeting of the American Society for Pharmacology and Experimental Therapeutics (1).

Astrazenca announced Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca's SAPHNELO® (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.1

Sagimet Biosciences Inc. reported that data from a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet's license partner Ascletis Bioscience Co. Ltd. (Ascletis) will be presented at the European Academy of Dermatology and Venerology (EADV) 2025 Congress taking place September 17-20, 2025 in Paris, France.

Sight Sciences, Inc. announced the results as published in the European Journal of Ophthalmology of a systematic review and meta-analysis of the clinical effectiveness, safety, humanistic and economic impact of the OMNI Surgical System (OMNI).

Nurix Therapeutics, Inc. announced the presentation of preclinical data from GS-6791/NX-0479, a novel IRAK4 protein degrader discovered as part of the company's ongoing research collaboration with Gilead Sciences.

Lexicon Pharmaceuticals, Inc announced the presentation of clinical data from the company's Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain

Regeneron Pharmaceuticals, Inc announced the primary endpoint was met in the Phase 3 OPTIMA trial investigating garetosmab in adults with fibrodysplasia ossificans progressiva (FOP).

Kymera Therapeutics announced that the positive results from the Phase 1 healthy volunteer clinical trial of KT-621, its first-in-class, oral STAT6 degrader, will be featured in two separate late-breaking oral presentations at the European Academy of Dermatology & Venereology (EADV) Congress being held September 17-20, in Paris, France, and at the European Respiratory Society (ERS) Congress being held September 27-October 1, in Amsterdam, Netherlands. Additionally, the Company will share new preclinical data in an EADV poster that builds upon KT-621's compelling characterization in disease-relevant contexts compared to dupilumab.,

Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).

Tonix Pharmaceuticals announced the in-licensing of worldwide rights to TNX-4800 (formerly known as mAb 2217LS)1, which is a long-acting human monoclonal antibody that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans.

Celldex announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival.

Arcutis Biotherapeutics, Inc. announced that new data on ZORYVE (roflumilast) efficacy across three common skin conditions—seborrheic dermatitis, atopic dermatitis, and psoriasis—will be presented at the 34th Annual European Academy of Dermatology and Venereology (EADV) Congress, which is taking place September 17–20, 2025, in Paris.

Dermata Therapeutics, Inc. announced the presentation of an abstract from its XYNGARI™ (also known as DMT310) Phase 3 Spongilla Treatment of Acne Research clinical trial (STAR-1) will be presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025 being held in Paris, France, from September 17-20th.

Incyte announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).

Innate Pharma SA provided Business Update

Oruka Therapeutics announced interim data from its Phase 1 trial of ORKA-001, the Company's long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France.

Arcutis Biotherapeutics, Inc announced that ZORYVE was presented with a 2025 Best of Beauty Breakthrough Award by Allure magazine, which is globally recognized as the most distinguished beauty award by industry professionals and consumers.

Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, the Company's first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax + azacitidine for newly diagnosed patients with acute myeloid leukemia (AML) unfit for intensive chemotherapy.

Enveric Biosciences announced that it has received a written response from the U.S. Food and Drug Administration (FDA) to its request for a Pre-Investigational New Drug (pre-IND) Type B meeting for its lead program, EB-003.

BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted an expansion of the cleared treatment protocols for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) to include an accelerated protocol for the treatment of patients with major depressive disorder (MDD) including those with comorbid anxiety symptoms.

Lantern Pharma Inc. announced the successful completion of its Phase 1a clinical trial (NCT05933265) for LP-184.

Adial Pharmaceuticals, Inc. announced receipt of the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held on July 29, 2025. The minutes provide the FDA's formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy.

MediciNova, Inc announced that an abstract regarding the Phase 2b/3 COMBAT clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients has been selected for a poster presentation at 36th International Symposium on ALS/MND to be held December 5-7, 2025 in San Diego, CA.

Rafael Holdings, Inc. announced today that data from Cyclo Therapeutics' Phase 3 TransportNPC™ open-label, single-arm sub-study evaluating Trappsol® Cyclo™ (hydroxypropyl-beta-cyclodextrin) for Niemann-Pick Disease Type C1 ("NPC1") were presented at the 15th International Congress of Inborn Errors of Metabolism (ICIEM).

Jyong Biotech Ltd. announced that it has completed patient enrollment in its Phase II clinical trial of MCS‑8, an investigational drug candidate for prostate cancer prevention (PCP), with more than 700 high-risk subject who have enrolled into this clinical trial since its commencement.

Coya Therapeutics, Inc. announced results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya's investigational biologic combination in an established in vivo lipopolysaccharide (LPS) mouse model of systemic and neuroinflammation.

Corbus Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.

Annovis Bio, Inc announced the publication of a new article in a peer-reviewed journal Biomolecules, which describes the pharmacokinetic (PK) profile of a new crystal form of buntanetap and compares it to the old form across several studies including mice, dogs, and humans.

MIRA Pharmaceuticals, Inc announced positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.

Pasithea Therapeutics Corp. announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.

CytoSorbents Corporation today provided a regulatory update on DrugSorb™-ATR.

ncolytics Biotech® Inc. nnounced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network (PanCAN).

Biomea Fusion, Inc. announced the presentation of preclinical data from its investigational menin inhibitor icovamenib in combination with semaglutide in a T2D animal model.

Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

Verona Pharma plc announces two posters on additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD"), will be presented at the European Respiratory Society ("ERS") International Congress 2025.

Shanghai Stock Exchange listed company HitGen Inc congratulates its partner BioAge Labs, Inc on the initiation of a Phase 1 clinical study of BGE-102, a novel, potent NLRP3 inhibitor developed from a hit compound identified using HitGen's industry-leading DEL technology platform.

Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on Friday September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease.

Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on Friday September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease.

Entera Bio Ltd. announced the presentation of a poster titled "A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome" at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress in Prague, Czech Republic, highlighting pharmacokinetic (PK) data relating to its oral GLP-2 analog program.

enVVeno Medical Corporation announced that it will file a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).

IceCure Medical Ltd. announced it has received regulatory approval from the Medical Device Division of Israel's Ministry of Health ("AMAR") for its next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes.

Kalaris Therapeutics, Inc. announced that it is now enrolling a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD).

Spyre Therapeutics, Inc. announced that the first patient has been dosed in its Phase 2 SKYWAY basket trial evaluating SPY072 in RA, PsA, and axSpA.

Krystal Biotech, Inc announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings.

Lipella Pharmaceuticals announced that Jonathan Kaufman, Chief Executive Officer of Lipella, will present a corporate overview and final results from Phase 2a trial of LP-10 in oral lichen planus at the Zacks SCR Life Sciences Virtual Investor Forum on September 18th, 2025 at 12:30pm EDT.

Palvella Therapeutics, Inc announced the successful completion of TOIVA, a Phase 2 trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of cutaneous venous malformations (cutaneous VMs).

aTyr Pharma, Inc. announced topline results from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease.

Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) was presented at the 150th Annual Meeting of the American Neurological Association (ANA), held in Baltimore, MD.

Kodiak Sciences Inc. announced today new data from the APEX study of KSI-101 presented at the Retina Society 58th Annual Scientific Meeting in Chicago, Illinois.

Viridian Therapeutics, Inc announced that enrollment is complete in REVEAL-1 and REVEAL-2, phase 3 clinical trials for VRDN-003 in patients with active and chronic TED, respectively.

Perspective Therapeutics, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with previously treated, histologically confirmed metastatic melanoma and positive melanocortin 1 receptor (MC1R) imaging scans.

Merck announced that Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab.

Novocure announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.

Belite Bio Inc announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1).

OS Therapies Inc. announced that the last patient enrolled in its OST-504 (previously ADXS-504) Phase 1b clinical trial in subjects with biochemically recurrent prostate cancer previously treated with radical prostatectomy (RP) or radiation therapy (external beam or brachytherapy) who are not currently receiving androgen ablation therapy has completed their last patient visit (NCT05077098).

Polyrizon Ltd. announced encouraging preclinical results supporting the performance of its PL-14 Allergy Blocker, part of its proprietary Capture & Contain (C&C) platform.

Precision BioSciences, Inc announced that the Company presented clinical data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV in patients with chronic Hepatitis B.

Inspira™ Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration ("FDA") submission.

MAIA Biotechnology, Inc. today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.

FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.

GRI Bio, Inc. today reported interim 6-week lung function results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

Lexicon Pharmaceuticals, Inc. announced the presentation of clinical data for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain (DPNP) at three upcoming medical meetings.

Liquidia Corporation announced today that the company will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium taking place September 18 – 20, 2025, in Seattle.

Amneal Pharmaceuticals, announced the U.S. Food and Drug Administration (FDA) approval of Amneal's sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals' Xyrem®.

Kairos Pharm announces that it will host a premier KOL event on Thursday, Sept. 18th at 5 p.m. ET / 2 p.m. PT to discuss diverse perspectives on the Company's interim efficacy results from a Phase 2 trial of its lead candidate, ENV105, in treating advanced prostate cancer patients.

Protagonist Therapeutics, Inc. announced the submission of an application to the European Medicines Agency (EMA) by Johnson & Johnson seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe plaque psoriasis (PsO).

Enlivex Therapeutics Ltd. today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline results for Allocetra™ in knee osteoarthritis (KOA) and detailing the next steps planned for its clinical development roadmap.

Maze Therapeutics, Inc. announced positive clinical results from the Phase 1 healthy volunteer study of MZE782, an oral small molecule targeting the solute transporter, SLC6A19.

Apogee Therapeutics, Inc. announced data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis was accepted for a late-breaker oral presentation at the upcoming EADV Congress 2025, to be held in Paris, France from September 17-20, 2025.

PureTech Health plc announced that the first participant has been dosed in the Phase 1 study of GlyphAgo™ (SPT-320 or Glyph Agomelatine).

Silexion Therapeutics Corp announced new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor activity.

Merck announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Conference on Vaccines, taking place in Lisbon, Portugal.

Revolution Medicines, Inc announced key clinical updates from its daraxonrasib Phase 1 clinical trials.

NeOnc Technologies announced that the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial.

Artelo Biosciences, announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal.

Hoth Therapeutics, Inc announced it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi).

Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept's New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a PDUFA date of July 11, 2026 for the application.

Purple Biotech announced that the Examining Division of the European Patent Office has issued an intention to grant a European Patent for Application No. 20168234.1, titled 'Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer'.

Incyte announced that it will present new data from its dermatology portfolio at the European Association of Dermatology and Venerology (EADV) 2025 Congress, held from September 17 – 20, in Paris.

TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain.

Assertio Holdings, Inc. announced that the company will present new data for SYMPAZAN (clobazam) Oral Film in a poster presentation at the 150th Annual Meeting of the American Neurological Association (ANA2025), September 13-16, 2025, Baltimore Marriott Waterfront, Baltimore.

Arrowhead Pharmaceuticals, Inc announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-MAPT, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies including Alzheimer's disease, a progressive neurodegenerative disease characterized by cognitive and functional decline.

Revelation Biosciences, Inc to review groundbreaking activity data from its Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease (CKD) patients.

Immuneering plans to announce updated overall survival data in first-line pancreatic cancer patients treated with atebimetinib + mGnP (N=34) with 9 months median follow up on Thursday, September 25, 2025. The Company additionally shared plans for two presentations at upcoming scientific conferences.

Waldencast plc announced that the U.S. Food and Drug Administration ("FDA") has approved Obagi® saypha® MagIQ™ injectable hyaluronic acid ("HA") gel, the first product in the Obagi® saypha® collection under the Obagi Medical brand.

Sagimet Biosciences Inc. announced that the Company will give two oral presentations and participate in a drug development panel at the 9th Annual MASH Drug Development Summit taking place September 29-October 1, 2025 in Boston, MA.

Instil Bio, Inc. announced that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. presented preliminary efficacy and safety data of ‘2510 (IMM2510/AXN-2510) as monotherapy in a Phase 1 study of patients in China with previously treated squamous non-small cell lung cancer (sq-NSCLC) at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 9, 2025.

PMV Pharmaceuticals, announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation.

Avidity Biosciences, Inc. announced positive new data from participants treated continuously with del-zota for one year in the EXPLORE44® and EXPLORE44-OLE™ trials.

Treace Medical Concepts, Inc announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2025 in Savannah, Georgia from September 10-13, 2025.

Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed.

Karyopharm Therapeutics Inc. announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients.

Avidity Biosciences, Inc. announced positive new data from participants treated continuously with del-zota for one year in the EXPLORE44® and EXPLORE44-OLE™ trials.

BioXcel Therapeutics, announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated BXCL501 had continued effects and consistent benefit with repeat dosing.

Greenwich LifeSciences, Inc announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.

Amgen and Kyowa Kirin Co., Ltd. announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD).

Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC).

Ionis Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ION582 for the treatment of Angelman syndrome (AS), a rare neurological disease that often presents in infancy and is characterized by profound intellectual disability, impaired communication, motor impairment and debilitating seizures.

Bausch + Lomb Corporation announced Clinical Ophthalmology has published results from an investigator-initiated study which evaluated the effectiveness of XIIDRA (lifitegrast ophthalmic solution) 5% in alleviating end-of-day (EOD) eye dryness and discomfort in symptomatic contact lens (CL) wearers.

Aclaris Therapeutics, Inc. announced that a late-breaking abstract on its open-label Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), was selected for oral presentation at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, being held September 17-20, 2025, in Paris, France.

Nektar Therapeutics announced today that it will present results from the ongoing REZOLVE-AD Phase 2b study at the 2025 European Academy of Dermatology and Venereology (EADV) Congress being held in Paris, France from September 17-20, 2025.

Sight Sciences, Inc. announced that UnitedHealthcare (UHC) has updated its Glaucoma Surgical Treatments policy to cover goniotomy, trabeculotomy, canaloplasty (ab interno), and combined canaloplasty (ab interno) and trabeculotomy procedures for adults (age 19 years or more), when deemed medically necessary for treating mild to moderate open-angle glaucoma (OAG) and cataract in adults currently being treated with ocular hypotensive medication.

Emergent BioSolutions Inc. announced that a contract modification has been executed in the amount of $56 million to supply ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to the U.S. government. Deliveries are expected to begin this month.

Xilio Therapeutics, Inc. announced the initiation of patient dosing in Phase 2 of an ongoing Phase 1/2 clinical trial evaluating efarindodekin alfa (XTX301), a tumor-activated IL-12, as a monotherapy in patients with certain advanced solid tumors.

Agenus Inc announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France's compassionate access (Accès compassionnel, or AAC) framework.

Jazz Pharmaceuticals plc announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation.

ArriVent BioPharma, Inc today presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the IASCLC 2025 annual World Conference on Lung Cancer (WCLC), in Barcelona, Spain.

Microbot Medical Inc. announced that Harel Gadot, CEO, President & Chairman, will highlight the recent FDA clearance of the LIBERTY® System, the first single-use, remotely operated robotic system for peripheral endovascular procedures, at the H.C. Wainwright Annual Investor Conference.

Moleculin Biotech, Inc announced updates to its active site status and recruitment for its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML).

Capricor Therapeutics today issued a statement regarding the U.S. Food and Drug Administration's (FDA) public posting of its Complete Response Letter (CRL) for the Biologics License Application (BLA) for Deramiocel, the Company's investigational cell therapy for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Serina Therapeutics, Inc. announced that it has entered into an agreement to access up to $20 million in financing led by Serina Board Director Greg Bailey, MD.

CRISPR Therapeutics announced that a late-breaking oral presentation highlighting the Company's Phase 1 clinical data of its investigational CRISPR/Cas9 in vivo gene editing therapy, CTX310™, targeting angiopoietin-related protein 3 (ANGPTL3) for cardiovascular and cardiometabolic disease, will be presented at the American Heart Association (AHA) Scientific Sessions 2025, taking place November 7 – 10, 2025, in New Orleans, Louisiana.

Regeneron Pharmaceuticals, Inc announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge Phase 3 trials in adults with moderate-to-severe cat or birch allergies. Both trials met their respective primary and key secondary endpoints.

Dianthus Therapeutics, Inc announced positive top-line data from the Phase 2 MaGic trial evaluating the safety and efficacy of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive (AChR+) generalized Myasthenia Gravis (gMG).

IDEAYA Biosciences, Inc. will present positive interim data at their 10-Year Anniversary R&D Day from their ongoing Phase 2 OptimUM-09 trial of darovasertib in the neoadjuvant setting for primary uveal melanoma (UM).

Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus chemoimmunotherapy (bendamustine plus rituximab), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.

Pulse Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company's Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the treatment of atrial fibrillation (AF).

Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore beginning at 3:15 p.m. SGT today.

Rapport Therapeutics, Inc announced that the Phase 2a clinical trial of RAP-219 (RAP-219-FOS-201) in patients with drug-resistant focal onset seizures met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period. In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline.

Alkermes plc announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).

Tonix Pharmaceuticals presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada

Pfizer Inc. and BioNTech SE announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® (COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19.

Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended that the Company's Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) should proceed to Cohort 2, 8mg tablet, without modification.

Biodexa Pharmaceuticals PLC. has launched its registrational Phase 3 trial of eRapa - its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP), a debilitating disease of the lower GI tract.

TG Therapeutics, Inc. announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company's anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS).

Cybin Inc announced completion of enrollment in its Phase 2 study evaluating CYB004, a proprietary deuterated dimethyltryptamine ("DMT") program, for the treatment of Generalized Anxiety Disorder ("GAD") and reaffirms top line data guidance expected in the first quarter of 2026.

Medicus Pharma Ltd is pleased to announce that the SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin, has commenced patient recruitment in Cleveland clinic Abu Dhabi (CCAD). Earlier this year, in May 2025, SKNJCT-004 received "study may proceed" approval from the UAE Department of Health.

Cocrystal Pharma, Inc. announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections.

Mirum Pharmaceuticals, Inc announced the completion of enrollment in the Phase 2b VISTAS study of volixibat, an investigational oral IBAT inhibitor, for the treatment of cholestatic pruritus in patients with primary sclerosing cholangitis (PSC).