In a surprise decision, the Food and Drug Administration said it would convene an advisory committee to discuss Sarepta Therapeutics,srpt) muscular dystrophy gene therapy, and SRPT stock fell on Friday.
X
Just two weeks ago, Sarepta said the FDA would not ask a panel of independent experts to weigh in on the risks and benefits of gene therapy for Duchenne muscular dystrophy. But the agency changed its mind during a late-night meeting, Sarepta said in a news release Thursday.
Sarepta is asking for accelerated approval, meaning it still hasn’t completed two Phase 3 studies of the drug SRPT-9001. But it assumes that treatments based on elevated levels of a key protein in patients work. Outside experts will debate whether the protein indicates a benefit for patients.
“While we now see the potential for greater near-term stock volatility with upcoming regulatory events, we still see many upsides for SRPT-9001,” RBC Capital Markets analyst Brian Abraham said in a note to clients.
In premarket trading at today’s stock market, SRPT stock fell 19.7% near 120.20.
More to follow.
Follow Allison Gatlin on Twitter @IBD_AGatlin,
You may also like:
IBD Stock of the Day continues its run with Lantheus breakout
Medicare Negotiations Undercut Biotech Stocks Regeneron, Halozyme
Want more IBD insight? Subscribe to our Investing Podcast!
Stocks To Buy & Watch: Top IPOs, Big & Small Cap, Growth Stocks
Profit from short-term trends with SwingTrader