How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene moxeparvovec), cleared for Duchenne muscular dystrophy (DMD). Shares of Cambridge, Mass.-based Sarepta (NASDAQ:SRPT) closed June 16 at $20.94, down $15.24, or 42%, as Wall Street digested the news.
Biopharma deal activity continued its record-breaking pace in 2025, reaching $103.76 billion in total value through the first five months, the highest year-to-date total in BioWorld’s records. That figure marks a nearly 20% increase over the $86.68 billion recorded during the same period in 2024.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Abbvie, Beone, Enanta Galderma, Innovia, Nuvation, Vascarta.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkyon, Bharat, Debiopharm, GSK, Nona, Third Harmonic, Visterra.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzinova, Angitia, Arthrosi, Biogen, Johnson & Johnson, Levicept, Merck, Novartis, Nurix , Samsung Bioepis, Sanofi, Schrödinger, Syndax, Third Harmonic, UCB.
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