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 product designed to reduce exposure to airborne respiratory viruse

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 common stockholders of $62.4 million, or $1.79 per basic a

BOSTON, Dec. 19, 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 the pricing of an underwritten public offering of 35,714,286 shares of its common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and accompanying common stock warrants to purch

Total national coverage footprint for PENFS increases to roughly 100 million covered livesCARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). T

Findings show Linus Health's AI can indicate Alzheimer's pathology before noticeable symptoms—enabling earlier action to help protect independence and preserve what makes us who we are BOSTON, Dec. 19, 2025 /PRNewswire/ -- AI can detect biological signs of Alzheimer's disease years before symptoms are noted by the patient or their loved ones using only a 3-minute digital assessment delivered in a physician's office. New research from Linus Health, an AI-driven brain health company pioneering ear

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 investigational oral carbapenem antibiotic being developed for the t

LONG BEACH, Calif. and TORONTO, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Glass House Brands Inc. ("Glass House" or the "Company") (CBOE CA: GLAS.A.U) (CBOE CA: GLAS.WT.U) (OTCQX: GLASF) (OTCQX:GHBWF), one of the fastest-growing, vertically-integrated cannabis companies in the U.S., applauds yesterday’s cannabis reform action from the Trump administration. “The executive order to reschedule cannabis to a Schedule III classification and the authorization of a pilot program for Medicare reimbursement o

BOSTON--(BUSINESS WIRE)--Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the completion of dose escalation (Part A) in its Phase 1/2 clinical trial of NDI-219216, the company's investigational non-covalent Werner syndrome helicase (WRN) inhibitor for the treatment of microsatellite instability-high (MSI-H) tumors. Data thus far from the

Enhertu's first-line breast cancer approval, unexpected death cases in a Daiichi Sankyo antibody-drug conjugate trial and positive readouts from Takeda's Sotyktu challenger made our news this week. In the last Fierce Pharma Asia weekly news roundup of 2025, Daiichi Sankyo scored a key FDA approval for AstraZeneca-partnered Enhertu in first-line HER2-positive breast cancer but paused a phase 3 trial of its Merck & Co.-partnered antibody-drug conjugate due to unexpected patient deaths

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Dec. 19, 2025 /PRNewswire/ -- Equity Insider News Commentary – The oncology sector's pivot toward platform-based precision therapies has signaled smart money abandoning single-asset risk for companies engineering multiple drugs from validated mechanisms[1]. Antibody-drug conjugate pipelines expanding past 200 clinical candidates demonstrate how platform technologies enable rapid target-s while preserving core therapeutic advantages, creating