"Sarepta Stock Soars 38% After FDA Expands Gene Therapy Approval"
TL;DR Summary
Peter Marks, a top FDA official, overruled staff and review teams to approve Sarepta Therapeutics' gene therapy Elevidys for nearly all Duchenne muscular dystrophy patients, despite the drug failing a Phase 3 trial and significant uncertainty about its benefits.
Topics:business#drug-approval#duchenne-muscular-dystrophy#fda#gene-therapy#healthmedicine#sarepta-therapeutics
- Top FDA official Peter Marks overruled staff to approve Sarepta gene therapy STAT
- Sarepta stock surges nearly 40% as investors cheer expanded use of gene therapy for Duchenne muscular dystrophy CNBC
- Sarepta Stock Surges on Expanded Approval for Elevidys. What Wall Street Thinks. Barron's
- FDA expands approval of first gene therapy for rare form of muscular dystrophy CNN
- Sarepta’s stock soars 38% after FDA expands approval for DMD drug MarketWatch
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