ELEVIDYS
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Sarepta Therapeutics Pauses ELEVIDYS Shipments in the U.S.
Sarepta Therapeutics is voluntarily pausing ELEVIDYS shipments in the U.S. to facilitate information exchange with the FDA and finalize safety labeling. This gene therapy treats Duchenne muscular dystrophy by delivering a micro-dystrophin gene. The pause will take effect July 22, 2025. The company emphasizes patient safety and maintaining a productive relationship with the FDA. ELEVIDYS is approved for Duchenne patients aged 4+ with confirmed DMD gene mutations.
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Sarepta Shares ELEVIDYS Safety Update, Implements Steps to Enhance Safety for Non-Ambulatory Duchenne Patients
Sarepta Therapeutics is taking action to address safety concerns with its gene therapy ELEVIDYS for Duchenne muscular dystrophy after a second fatal liver failure case. The company is implementing a new immunosuppression regimen, pausing shipments for non-ambulatory patients, and halting dosing in its ENVISION study. Sarepta will discuss these developments in an investor call on June 16, 2025.