Tag: FDA

ATLANTA, July 22, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) complied with federal securities laws. On July 22, 2025, Replimune announced it received a Complete Response Letter (“CRL”) from the FDA regarding the Biologics License Application (“BLA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. In the CRL, the FDA indicated “that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” Following this news, the price of the Company’s stock dropped. 

WEXFORD, Pa., July 22, 2025 (GLOBE NEWSWIRE) -- Coeptis Therapeutics Holdings, Inc. (Nasdaq: COEP) (“Coeptis” or the “Company”), a next-gen technology and biopharmaceutical company, is pleased to announce the extinguishment of its convertible note with YA II PN, Ltd (“Yorkville”).  

MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise.

COPENHAGEN, Denmark, July 22, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that Health Canada has accepted for review the Company’s application for licensure of the single-dose, virus-like particle (VLP) chikungunya vaccine candidate, CHIKV VLP, for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application screening acceptance by the Directorate confirms that the New Drug Submission is complete and begins a standard review procedure, potentially supporting approval of the vaccine in the first half of 2026.

KØBENHAVN, Danmark, 22. juli 2025 – Bavarian Nordic A/S (OMX: BAVA) offentliggjorde i dag, at de canadiske lægemiddelmyndigheder, Health Canada, har accepteret selskabets ansøgning om markedsføringstilladelse for den virus-lignende partikel (VLP)-baserede, enkelt-dosis chikungunyavaccinekandidat, CHIKV VLP, til forebyggelse af sygdom forårsaget af chikungunyavirus hos personer på 12 år og ældre. Dermed starter myndighedernes standardgennemgang, hvilket potentielt understøtter godkendelse af vaccinen i første halvår 2026.

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In UroGen Pharma (URGN) To Contact Him Directly To Discuss Their Options

CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI^® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau.