TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan –...Read more
TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19...Read more
CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that James Porter, Ph.D., Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:00 a.m. PT in San...Read more
Four autoimmune patients treated to date demonstrate deep B-cell depletion sustained for at least 28 days; initial efficacy data suggest significant clinical improvement in patients dosed at the 100 million cell dose, with the first systemic lupus erythematosus (SLE) patient achieving Definitions of Remission in SLE (DORIS) remission through Month 6 An additional Phase 1 basket trial has been initiated for zugo-cel in refractory...Read more
PDUFA target action date of June 30, 2026 Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition Veligrotug now has both Priority Review and Breakthrough Therapy Designations, each following requests which included data on veligrotug’s (i) consistent and robust improvement and resolution of diplopia...Read more
Introduction of AVT05 supported by NHS England tender award in the United Kingdom REYKJAVIK, Iceland, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that launches are underway in Europe for Gobivaz® (golimumab), Alvotech’s biosimilar to Simponi® (golimumab), also known as AVT05...Read more
The BLA was Resubmitted with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Priority Review was Requested LANGHORNE, Pa. / Dec 22, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced today that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer. The...Read more
Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals NEWTOWN SQUARE, Pa., Dec. 22, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global...Read more
FRAMINGHAM, Mass. & SALISBURY, England / Dec 22, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. EKTERLY is...Read more
NEW YORK, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 7:30 AM PT in San Francisco, California. The event will...Read more
This acquisition establishes Niagen Bioscience as the sole owner of the most comprehensive and defensible intellectual property portfolio in the NAD+ industry LOS ANGELES / Dec 22, 2025 / Business Wire / Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that it has acquired a comprehensive portfolio of existing patents...Read more
BOSTON, Dec. 22, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced its partnership with Carnegie-Mellon University (CMU) for an award by the Advanced Research Projects Agency for Health (ARPA-H) for its POSEIDON program (Platform Optimizing SynBio for Early Intervention and Detection in Oncology). With Ginkgo Bioworks serving as the Commercial Partner, the project will also be led by Rebecca Taylor (principal investigator),...Read more
Single-ascending dose portion of study has successfully completed 2.5 and 7 mg / kg levels Dose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profile Substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases Given encouraging efficacy and safety, the trial will continue as planned and further updates are...Read more
Enrollment Completed in C-BEYOND Phase 3 Trial with More Than 880 HCV Treatment-Naïve Patients in US and Canada C-BEYOND Topline Results Expected Mid-2026 C-FORWARD Phase 3 Trial, Conducted Outside North America, Enrollment Completion Expected Mid-2026 with Topline Results Anticipated Year-End 2026 C-BEYOND AND C-FORWARD are the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for Treatment of HCV BOSTON, Dec....Read more
Results published in Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT) After up to 36 months of follow-up, patients demonstrated high limb salvage, low rates of infection, no unprovoked structural failures Results represent first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit DURHAM, N.C., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc....Read more
Novel PTH analog achieves sustained calcium elevation for >3 days from single oral tablet, supporting development path toward once-daily alternative to daily injections JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data...Read more
The engagement establishes a multi-phase framework to support AI enabled capital efficient development of Teverelix, a next generation GnRH antagonist, as a first in class market product for acute urinary retention (AURr) and high CV risk prostate cancer collectively representing ~$6 billion in potential market opportunity PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / December 22, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus"...Read more
HAIFA, Israel, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Pluri, Inc. (“Pluri”, the “Company”, “we” or “us”) (Nasdaq, TASE: PLUR), a leading biotechnology company leveraging its proprietary platform for cell-based solutions through a collaborative network of ventures, today announced expansion of its manufacturing agreement signed in 2024 with Remedy Cell Ltd. (“Remedy Cell”), an innovative biopharmaceutical company developing stem cell-derived,...Read more
Clinical and Biomarker Outcomes Expected to Be Reported in Q1 2026 CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001...Read more
BOSTON, Dec. 22, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, announced the appointment of Jack E. Stover to its Board of Directors. Mr, Stover will join the Audit and the Nominating Committees as Dr. Magda Marquet steps down from the Audit Committee. Mr. Stover brings more than three decades of...Read more
Vancouver, British Columbia--(Newsfile Corp. - December 22, 2025) - Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU) ("Entheon" or the "Company") is pleased to announce that it has entered into a binding Letter of Intent (the "LOI") dated December 18, 2025, with Nutravisor Inc. ("Nutravisor") whereby Entheon will acquire all of the issued and outstanding common shares of Nutravisor (the "Proposed Transaction"). Upon...Read more
BioMarin to Gain Galafold® (migalastat) for Fabry Disease and Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease, Adding Two Marketed, High-Growth Products with $599 Million in Revenue Over Past Four Quarters Provides Opportunity to Expand Access to Galafold and Pombiliti + Opfolda to Patients in New Markets Across BioMarin's Global Footprint; Pending U.S. Galafold Patent Litigation Resolved Will...Read more
MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM FDA Approval Based on Results of SEQUOIA-HCM MYQORZO is Company’s First FDA-Approved Medicine Company to Host Investor Conference Call Today at 4:30 PM Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug...Read more
IRVING, Texas, Dec. 19, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that Providence Swedish Cancer Institute and the institute's focused translational research extension, the Paul G. Allen Research Center, have joined the Caris Precision Oncology Alliance™ (Caris POA). The Providence Swedish Cancer Institute,...Read more
FOSTER CITY, Calif. / Dec 19, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that it has entered into a subscription agreement with entities associated with TCGX, an institutional investor, for a private placement of 1,000,000 shares of its common stock (the “Common Stock”). The Common Stock issued to the private placement investors at closing will be priced at $68.48 per...Read more
Improvements observed in key non-invasive markers of fibrosis across treatment arms versus placebo, with continued reductions from 24-week timepoint Additional weight loss from 24 to 48 weeks with 1.8 mg dose, without plateauing Favorable tolerability profile of pemvidutide preserved at 48 weeks, reinforced by low treatment-related discontinuation rate End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3...Read more
NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for...Read more
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an...Read more
ISELIN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to...Read more
Reducing inflammation helps create a regenerative environment in the Central Nervous System TORONTO and HAIFA, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially...Read more
New Patent Expands IGC Pharma's Pharmaceutical Cannabinoid Portfolio Beyond Alzheimer's Disease POTOMAC, MD / ACCESS Newswire / December 19, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office (USPTO) has officially...Read more
The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal...Read more
With approximately $9.5 million in cash reserves and no debt, the Company is ready to leverage strengthened vertical integration as clinical-grade psilocybin moves into Phase IIb trials NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced...Read more
BioNTech has completed its exchange offer to acquire CureVac Acquisition complements BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing In total, approximately 86.75% of CureVac shares were tendered; BioNTech expects to complete the compulsory acquisition of the remaining CureVac shares in January 2026 as part of the previously announced post-offer reorganization CureVac...Read more
WILMINGTON, Del. / Dec 18, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced today that it will present at the 44th Annual J. P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 am (PST). The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to...Read more
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with...Read more
Up to $54.3 million CEPI investment aims to help advance Moderna's H5 pandemic influenza vaccine candidate to licensure Partnership strengthens global preparedness against a significant pandemic threat If licensed and in the event of an influenza pandemic, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing OSLO, NORWAY and...Read more
RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor...Read more
SAN DIEGO / Dec 18, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Catherine Owen Adams, Chief Executive Officer will represent the company in a session scheduled on Tuesday, January 13, 2026, at 9:45 a.m. Pacific Time / 12:45 p.m. Eastern Time. A live webcast of Acadia’s presentation will be accessible on the...Read more
CAMBRIDGE, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that John Evans, chief executive officer of Beam, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 5:15 p.m. PT in San Francisco. The live webcast will be available in the investor section of the...Read more
BOSTON and SAN DIEGO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological and psychiatric disorders, today announced that management plans to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at...Read more
PALO ALTO, Calif., Dec. 18, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock, which includes 1,043,478 shares sold pursuant to the underwriters' exercise in full of their...Read more
NEW YORK / Dec 18, 2025 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that Rob Barrow, Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 14, 2026 at 2:15 p.m. PT. “It is a privilege to...Read more
DefenCath® demonstrated a 72% reduction in CRBSI and 70% reduction in hospitalizations secondary to CRBSI BERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being...Read more
WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2025 at 1:30 PM PT. A simultaneous webcast will be available in the Investors section of...Read more
ROCKVILLE, Md., Dec. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference. Presentation DetailsDate and Time: Wednesday, January 14, 2026 at 10:30 a.m. PT Location: Westin St. Francis, San Francisco, CA A live webcast of the presentation can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay...Read more
MINNEAPOLIS / Dec 18, 2025 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the...Read more
The overview presentation will review some of the Company’s recent achievements as well as the outlook for upcoming data milestones JERUSALEM, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update...Read more
BOSTON / Dec 18, 2025 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announces that the Board of Directors has appointed Robert Lyne as Chief Executive Officer (CEO), and as a member of the Board of Directors, effective immediately. Robert Lyne commented: “I’m honored to...Read more
BALA CYNWYD, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company’s management team will present and participate in 1x1 investor meetings at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January...Read more
NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it has requested the...Read more
The combination of denifanstat and resmetirom was generally well-tolerated Pharmacokinetic (PK) results support further development of the combination A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics...Read more
FREDERICK, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced the appointment of Adrian Bot, M.D., Ph.D., to the Company’s Board of Directors. Dr. Bot is a biopharma executive with three decades of experience in research and development (R&D) with a focus on immune, cell, gene therapy...Read more
ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), today announced it will present the Company’s latest developments and outlook for 2025 at the 44th Annual J.P. Morgan Healthcare Conference, taking place...Read more
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway Isaralgagene civaparvovec continues to show favorable safety and tolerability profile Sangamo expects to complete Biological License Application (BLA)...Read more
CHICAGO and FORT WORTH, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3β (GSK-3β), today announced that data from its Phase 2 study evaluating elraglusib in metastatic pancreatic cancer...Read more
Trial to assess cadisegliatin as potential adjunctive therapy to insulin in patients with T2D HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in collaboration with M42’s Insights Research Organization & Solutions (IROS), a leading United Arab Emirates (UAE)-based contract research...Read more
Collaboration to leverage CAMP4’s RAP Platform® to accelerate development of novel antisense oligonucleotides (ASOs) for neurodegenerative and renal diseases CAMP4 to receive $17.5 million upfront and eligible for additional milestone-based payments, in addition to tiered royalties CAMBRIDGE, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4” or “the Company”) (Nasdaq: CAMP), a clinical-stage...Read more
Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD) KOL event planned for early January to...Read more
Event to be held January 6th, 2026, at 10 a.m. EST BETHESDA, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that it will host a virtual key opinion leader (KOL) event, “Understanding GCase Substrates in Parkinson’s...Read more
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071 There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs) Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2...Read more
Enrollment will begin in January 2026 Participants will be treated with buntanetap for 36 months The study aims to enroll 500 patients MALVERN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced...Read more
46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC at 5.4 mg/kg 71% confirmed ORR and 100% DCR observed with MICVO in combination with KEYTRUDA® (pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg and 4.4 mg/kgUpdated data from ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC expected mid-2026; updated data from ongoing Phase 1/2 study evaluating MICVO in...Read more
LA JOLLA, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in the randomized, placebo-controlled Phase 2 clinical trial, the OXTOX study (Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer)....Read more
The LOI Aligns with Federal Priorities on Fentanyl Crisis, Artificial Intelligence, and Quantum Technology ORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) ("Nutriband" or the "Company"), a developer of transdermal pharmaceutical products including abuse-deterrent technologies, today announced the signing of a non-binding Letter of Intent ("LOI") with the Qvanta Group of Companies. The...Read more
No treatment-related adverse toxicity was observed across completed GLP studies, with consistent systemic exposure following oral administration. MIAMI, FL / ACCESS Newswire / December 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today announced...Read more
The contemplated financing transactions would provide up to $12 Million in capital to support Celularity’s strategic priorities around longevity and preservation of human performance. FLORHAM PARK, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced that it has entered into two binding term...Read more
Full-Year Revenues of $18.6 million and Net Loss of $2.2 million MISSISSAUGA, Ontario, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its fiscal year and fourth quarter ended September 30, 2025 (“2025” and “Q4”) with revenues for those periods reflecting reduced antigen sales into China and cancellation of a...Read more
Phase 3 Development Program of Novel Selective Estrogen Receptor Modulator (SERM) Represents Potential Multi-Billion Dollar Opportunity as Treatment Option for Patients with ESR1-Mutations Financing Co-Led by Commodore Capital, Perceptive Advisors and TCGX Supports Development of Lasofoxifene through Phase 3 Clinical Topline Data Readout and Regulatory Milestones Conference Call Today at 8:30 am Eastern Time BOTHELL, Wash., Dec....Read more
BOSTON, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and...Read more
Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Cambridge, Massachusetts, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company...Read more
Subject enrollment expected to begin in Q1 2026 CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection There are no approved treatments or vaccines currently available for norovirus infection BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the...Read more
Study results support advancing SGX945 in this difficult-to-treat orphan disease Results suggest potential durability of response for maintenance therapy PRINCETON, N.J., Dec. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that...Read more
Pulmatrix continues to support Cullgen in seeking approval for their merger from the China Securities Regulatory Commission FRAMINGHAM, Mass., Dec. 18, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical...Read more
WINNIPEG, Manitoba, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (the “Company”, “Kane” or “Kane Biotech”) announces that today it has completed its previously announced non-brokered private placement offering (the “Offering”) of common shares of the Company (“Shares”). At the closing of the Offering, Kane issued 14,000,000 Shares at a price of $0.05 per Share for gross proceeds of $700,000 to an insider of the...Read more
HALIFAX, Nova Scotia, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, is pleased to announce that it has closed the first tranche of its previously announced non-brokered private placement for aggregate gross proceeds of C$177,500 (the “Private Placement”). The Private...Read more
December 18, 2025 - Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX) (“Biodexa” or the “Company”), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the pricing of a best efforts public offering of an aggregate of (i) 157,000 units (the “ADS Units”), with each unit consisting of (A) one American depositary share (representing 100,000...Read more
New platform is expected to substantially increase manufacturing capacity and lower production costs, enabling investment in expanding pipeline FDA has accepted Alnylam’s enzymatic ligation manufacturing platform into its Emerging Technology Program, fast-tracking global regulatory engagement CAMBRIDGE, Mass. / Dec 17, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today...Read more
Phase 2b BiRCh Study of Brensocatib in CRSsNP Did Not Meet Primary or Secondary Efficacy Endpoints; Safety Consistent with Previous Studies; Insmed Discontinues CRSsNP Program Company Acquires Phase 2 Ready Monoclonal Antibody for Potential Respiratory and Immunological & Inflammatory Indications BRIDGEWATER, N.J., Dec. 17, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company...Read more
Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab is the first CD19- and CD20-dual-targeted immunotherapy combination regimen approved for eligible patients in Europe with relapsed or refractory FL Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and lenalidomide in the Phase 3 inMIND registration trial In Western...Read more
CAMBRIDGE, MA / ACCESS Newswire / December 17, 2025 / Moderna, Inc. (Nasdaq:MRNA) today announced it will present at the 44th annual J.P. Morgan Healthcare Conference on Monday, January 12th at 7:30 p.m. ET / 4:30 p.m. PT. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's...Read more
Breadth of Scientific Evidence: The acceptance of 1 oral presentation, 5 digital oral presentations and 16 posters reflect an expanding dataset for obefazimod, including additional efficacy, safety, and cytokine data from the Phase 3 ABTECT Induction Trials in moderate-to-severely active ulcerative colitis (UC) Novel Anti-Fibrotic Preclinical Findings: Oral presentation on Saturday, February 21, 2026, “Obefazimod shows first evidence...Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that the Company’s management plans to present at the...Read more
Approval Triggers Milestone Payment of $7.5 Million from Sanofi; Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with...Read more
SAN FRANCISCO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671, the company’s lead oral small molecule amylin receptor agonist for the treatment of obesity. ACCG-2671 was...Read more
SOMERSET, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that Ying Huang, Ph.D., the company’s Chief Executive Officer, will present the latest company updates at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on Wednesday, January 14th, 2026, at 9:00 a.m. PT. The live webcast will be available to investors and...Read more
WATERTOWN, Mass., Dec. 17, 2025 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 7:30 a.m....Read more
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 3:45 p.m. PT in San Francisco. A...Read more
BOSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, today announced that the Company will present at the J.P. Morgan 2026 Healthcare Conference on January 14, 2026. Presentation Details Date: Wednesday, January 14, 2026 Time: 7:30 AM PT Webcast Link: cmpx.info/jpmorgan Virtual/Replay...Read more
FREMONT, Calif. / Dec 17, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of a new study in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR). The paper, titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," details results from Dr. Rodrigo Toledo...Read more
| Company | Change | Last Trade |
|---|---|---|
| Abivax | 22.38 19.47 | $137.32 |
| Madrigal Pharmaceuticals | 17.57 2.97 | $608.59 |
| Regeneron Pharmaceuticals | 10.91 1.42 | $778.88 |
| Ascendis Pharma | 9.77 4.89 | $209.77 |
| Praxis Precision Medicines | 9.66 3.54 | $282.59 |
| Alnylam Pharmaceuticals | 8.56 2.14 | $408.80 |
| Lyell Immunopharma | 6.72 20.16 | $40.05 |
| Krystal Biotech | 6.61 2.75 | $247.42 |
| Zenas BioPharma | 5.53 15.30 | $41.68 |
| Bolt Biotherapeutics | 5.01 894.64 | $5.57 |
| Cytokinetics | 4.73 7.54 | $67.46 |
| Monopar Therapeutics | 4.62 6.73 | $73.25 |
| MBX Biosciences | 4.38 14.40 | $34.80 |
| Mirum Pharmaceuticals | 3.84 4.94 | $81.58 |
| Inhibrx | 3.45 4.01 | $89.58 |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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