Sarepta Therapeutics Faces Regulatory and Market Challenges Amid Shipment Pauses and Stock Decline
TL;DR Summary
Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, Elevidys, faces significant hurdles to return to the market after safety concerns, including liver injuries linked to patient deaths, making its re-approval challenging and potentially risking license revocation, according to a senior FDA official.
Topics:top-news#duchenne-muscular-dystrophy#elevidys#fda#health#safety-concerns#sarepta-therapeutics
- Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says statnews.com
- Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S. Sarepta Therapeutics
- Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths The New York Times
- Sarepta to pause gene therapy Elevidys shipments in U.S. CNBC
- Sarepta Stock Is Falling. How Its Crisis Went From Bad to Worse. Barron's
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