Sarepta's Gene Therapy Faces FDA Setback, Stock Plummets.
TL;DR
Sarepta Therapeutics' stock crashed nearly 20% after the FDA announced it would hold an advisory committee to discuss the risks and benefits of its gene therapy for Duchenne muscular dystrophy, despite the company's belief that it had met the requirements for accelerated approval. The FDA's decision to hold the advisory committee meeting before the May 29 approval decision date has raised concerns about a potential extension of the approval date. However, some analysts remain optimistic about the potential for Sarepta's gene therapy to ultimately gain approval.
Topics:business#accelerated-approval#advisory-committee#business#fda#gene-therapy#sarepta-therapeutics
- Sarepta Crashes On An Unexpected Roadblock For Its Gene Therapy Investor's Business Daily
- In a U-turn, FDA orders AdComm for Sarepta's DMD gene therapy FierceBiotech
- Sarepta Falls on Drug Approval Doubts. Buy the Stock, Say Analysts. Barron's
- Sarepta Therapeutics Announces Advisory Committee Meeting will be Held for SRP-9001 Yahoo Finance
- Sarepta stock -20% on FDA advisory meeting for its muscular dystrophy treatment (SRPT) Seeking Alpha
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