Tag: FDA

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Sarepta To Contact Him Directly To Discuss Their Options

ATLANTA, July 25, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (1) Defendants recklessly overstated the IGNYTE trial’s prospects, given material issues that defendants knew or should have known of, which resulted in the FDA deeming the IGNYTE trial inadequate and not well-controlled; and (2) as a result, defendants’ statements about Replimune’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all times.

CONSHOHOCKEN, Pa., July 25, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), announced today that it will release its second-quarter 2025 financial results on Wednesday, Aug. 5, 2025, prior to the open of the U.S. financial markets.

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”²

NEW YORK und MAINZ, Deutschland, 25. Juli 2025 — Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, „CHMP“) der Europäischen Arzneimittel-Agentur (European Medicines Agency, „EMA“) eine positive Beurteilung für die Marktzulassung (Marketing Authorization) des an LP.8.1 angepassten monovalenten COVID-19-Impfstoffs (COMIRNATY^® LP.8.1) der Unternehmen für die aktive Immunisierung zur Vorbeugung von COVID-19 verursacht durch SARS-CoV-2 bei Personen ab 6 Monaten ausgesprochen hat. Die Anpassung basiert auf der Empfehlung der Notfall-Taskforce (Emergency Task Force, „ETF“) der EMA, die vorschlägt, COVID-19-Impfstoffe zu aktualisieren, um die LP.8.1-Variante für die Impfkampagne 2025-2026 abzudecken. Die Notfall-Taskforce erklärte: „Eine Anpassung an LP.8.1 wird dabei helfen, die Wirksamkeit der Impfstoffe gegen das sich fortlaufend weiterentwickelnde SARS-CoV-2 aufrechtzuerhalten.“² 

Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $747.5M (€637.5M)

Schlieren / Zurich, Switzerland, 25 July, 2025 – Memo Therapeutics AG ("MTx”), a late-stage biotech company translating unique immune responses into superior medicines to treat viral infections and cancer, today announced results from its Phase II clinical trial evaluating potravitug, a highly potent human BK polyomavirus (“BKPyV”)-neutralizing monoclonal antibody, for the treatment of BKPyV infection in kidney transplant recipients (“KTR”).