Disc is seeking accelerated approval and priority review of its NDA submissionFDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Fo ...

NEW YORK, Sept. 30, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it will host a virtual R&D Day on Wednesday, October 29, 2025 at 10:00 AM ET featuring key opinion leaders (KOLs), alongside company management, to discuss the unmet medical need and evolving treatment landscape for acute myeloid leuke ...

SARASOTA, FL, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has entered into definitive agreements for the purchase and sale of 2,857,143 shares of common stock at a purchase price of $0.875 per share in a registered direct offering priced at-the-market under Nasdaq ...

The combined company, Clywedog Therapeutics, will bring a portfolio that includes three differentiated, clinical stage product candidates which are being studied for the prevention/reversal of Type 1 and Type 2 Diabetes and the treatment of Celiac Disease.Four key value-driving milestones are expected within 18 months, including clinical proof of concept in multiple indications. Estimated cash runway for combined company extends through 2027.Transaction projected to close in the first half of 2026. The comb ...

~ Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 ~ RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in its Phase 2 EXPLORE-OSA trial of lorundrostat ...

Accessibility StatementSkip Navigation One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY, Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum d ...

-- AjD Represents an Area of Significant Unmet Need; No U.S. Food and Drug Administration (FDA)-Approved Therapies Available -- -- Following Positive Topline Data in RECONNECT Phase 2 Trial, Expect to Initiate Phase 3 Trial of RE104 in Postpartum Depression (PPD) in 2026 and RECLAIM Phase 2 Trial in Generalized Anxiety Disorder (GAD) in 1Q 2026-- MORRISTOWN, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Reunion Neuroscience, Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatm ...

Accessibility StatementSkip Navigation In preparation for health authority interactions in pursuit of marketing approvals in Europe  PRINCETON, N.J., Sept. 30, 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 the expansion of its European Medical Advisory Board (MAB) to provide additional medical/clinical str ...

BEDFORD, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (Nasdaq: OCUL) (“Ocular”, the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced the pricing of an underwritten offering of 37,909,018 shares of its common stock at an offering price of $12.53 per share for gross proceeds of approximately $475.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. All of th ...

WAYNE, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the Company will host it’s 2025 R&D Day in Midtown, New York on Tuesday, October 14, 2025 at 8:00 AM ET to discuss the Company’s progress in addressing therapeutic gaps in immuno-inflammatory markets. To register, please click here. The event will feature presentations by Acla ...