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Press releases published on September 4, 2025
SPEAR Study Group to Present its Recommended Long COVID Antibody Study Design Featuring Invivyd’s VYD2311 At RECOVER-TLC Workshop September 9-10, 2025
SPEAR proposal reflects current evidence on monoclonal antibodies in treatment for Long COVID and identifies VYD2311 as a promising next-generation candidate for the clinical study Recommendation is for a robust, comprehensive, translational study to …
Neuphoria Therapeutics Completes Target Enrollment in Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder (SAD)
BURLINGTON, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced the …
Hinge Bio Expands Leadership Team to Drive Clinical Development of GEM-DIMER™ Programs and Announces Publication in Scientific Reports
Paul Brunetta, M.D., joins as Chief Medical Officer; Kristen Quigley joins as Chief Clinical Operations Officer; Alpana Naresh, Ph.D., joins as Vice President and Head, CMC Strategy and Manufacturing Hinge Bio publishes differentiated in vivo data …
NextCure to Present at the H.C. Wainwright 27th Annual Global Investment Conference
BELTSVILLE, Md., Sept. 04, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced that it …
Climb Bio to Host Webcast Highlighting CLYM116 and the IgA Nephropathy (IgAN) Opportunity on September 29, 2025
WELLESLEY HILLS, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, today announced details for the CLYM116 webcast event, which is set for …
C4 Therapeutics Highlights Recent Achievement in Biogen Collaboration
WATERTOWN, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that its partner Biogen has had its …
Breckenridge Distillery and Denver Broncos Kick Off Fifth Year of Partnership with New Lineup of Spirits, Including Limited-Edition Broncos Honey Whiskey
BRECKENRIDGE, Colo., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Breckenridge Distillery, an award-winning craft distillery and spirits brand by Tilray Brands, Inc. (NASDAQ: TLRY; TSX: TLRY), is raising a glass to its fifth consecutive year as an official partner …
Nusano Announces September Conference Schedule
WEST VALLEY CITY, Utah, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Nusano, a leader in advanced isotope and energy technologies, today announced its September conference schedule. Nusano CEO Chris Lowe will participate in panel discussions and company leadership …
Pulmovant Receives Orphan Drug Designation in Japan for Mosliciguat for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Orphan drug designation from Japan’s Ministry of Health, Labour and Welfare provides key regulatory benefits, including priority review and extended market exclusivity for potential treatments targeting diseases for which there is no sufficient alternative …
Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™
NDA remains on track for FDA PDUFA goal date of January 31, 2026 Commercial planning continues enabling rapid launch following approval WARREN, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “ …
Walden Biosciences Announces Key Initiatives to Advance Clinical Pipeline and Support Phase 2 Program for WAL0921 in Rare Kidney Diseases
Engages Former FDA Director of Division of Cardiology and Nephrology, Norman Stockbridge, M.D., Ph.D., to Advise on Walden’s Clinical Pipeline in Rare Kidney Diseases Utilizes Rare Kidney Disease Patient Advocacy Group to Broaden Awareness and Outreach …
Cancer Focus Fund Appoints Distinguished Industry Experts David R. Epstein and Michael Margolis as Advisors to Its Investment Committee
—Epstein and Margolis Bring Decades of Business Expertise and Industry Leadership to Cancer Focus Fund as It Prepares for Its Next Round of Investments— HOUSTON, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Cancer Focus Fund, LP, a unique investment fund established …
BPGbio Announces Completion of Enrollment for Phase 2b Trial of BPM31510 for Glioblastoma (GBM)
Topline Phase 2b Clinical Data Expected in 1H 2026 Trial-in-Progress Presentations Scheduled for ESMO and SNO in Fall 2025 BPM31510 has Received Orphan Drug Designation from the U.S. FDA for the Treatment of GBM BOSTON, Sept. 04, 2025 (GLOBE NEWSWIRE) -- …
BioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
NEW HAVEN, Conn., Sept. 04, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO …
Algernon Pharmaceuticals Announces Name Change to Algernon Health
VANCOUVER, British Columbia, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare company announces that it is changing its name to Algernon Health …
Skye’s CB1 Inhibitor, Nimacimab, Demonstrates Superior Weight Loss and Differentiated Mechanisms from Monlunabant, and Continues to Show Enhanced Combination with Tirzepatide with Durable Post-Treatment Weight Maintenance in DIO Model
Skye shares new preclinical DIO data at virtual KOL event Nimacimab + tirzepatide demonstrates over 40% weight loss in multiple preclinical DIO studies Nimacimab demonstrates durable post-treatment weight loss compared to tirzepatide Nimacimab reduced …
Join XORTX for an Exclusive Live Investor Webinar and Q&A Session on September 10
CALGARY, Alberta, Sept. 04, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and …
Agios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia
PDUFA goal date extended by three months from September 7, 2025, to December 7, 2025 CAMBRIDGE, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering …
GT Biopharma to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
The Company is available for one-on-one meetings at the H.C. Wainwright Conference September 8-10, 2025 in New York City Phase 1 trial evaluating GTBP-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues …