2023-03-16 18:06:49 ET
- U.S. biotech company Sarepta Therapeutics ( NASDAQ: SRPT ) on Thursday said the FDA's Office of Therapeutics has determined that an advisory committee meeting will be held for SRP-9001 in advance of the May 29, 2023 regulatory action date.
- Shares -19.7% at $120.25 after hours.
- “While we are disappointed that we must communicate a change in decision after our prior statement on the topic, we are not disappointed with the decision to hold an advisory committee. We had been preparing for an advisory committee meeting from the filing of the BLA in the fall of 2022. We will be well prepared, and look forward to presenting the wealth of evidence supporting the transformative potential of SRP-9001," Sarepta CEO Doug Ingram said in a statement.
- SRP-9001 is Sarepta’s investigational gene therapy for the treatment of Duchenne muscular dystrophy.
- Press Release .
For further details see:
Sarepta stock -20% on FDA advisory meeting for its muscular dystrophy treatment