Talk Bio

Sarepta Therapeutics has effectively pushed back the timeline for its Elevidys (delandistrogene moxeparvovec) gene therapy due to ongoing safety and regulatory scrutiny. The FDA requested that Sarepta suspend distribution of Elevidys and placed related clinical trials on hold after multiple fatalities tied to Sarepta gene therapies raised safety concerns. Sarepta agreed to a voluntary pause on all U.S. shipments of Elevidys, originally restricting use to ambulatory patients and later resuming shipments only for ambulatory Duchenne muscular dystrophy (DMD) individuals after the FDA allowed it to resume. However, the FDA is requiring additional safety data and new study requirements, which will likely delay broader commercialization and full restoration of the therapy’s label. Emergent BioSolutions has initiated a major restructuring program, cutting approximately 90 employees across its organization as part of a broader plan to reduce costs and strengthen its long‑term financial p...