雅虎香港財經 Sarepta Plunges As FDA Takes Surprise Turn; AdComm Meeting Set For Duchenne Gene Therapy
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The FDA will hold an advisory committee meeting related to Sarepta Therapeutics Inc's (NASDAQ: SRPT) SRP-9001 (delandistrogene moxeparvovec) marketing application.
SRP-9001 is Sarepta's investigational gene therapy for treating Duchenne muscular dystrophy, developed in partnership with Roche Holdings AG (OTC: RHHBY).
"This change adds drama to the equation," said Baird analyst Brian Skorney in a Reuters report. He added that the FDA's inconsistency might signal more internal debate than anticipated.
A date has not been set for the adcomm meeting, but it will be held sometime before May 29, granted as the PDUFA date under priority review status.
In its Q4 earnings release, Sarepta said the mid-cycle meeting is complete, and FDA does not plan to hold an advisory committee for SRP-9001.
The meeting will likely focus on the clinical trial's surrogate endpoint, biomarkers, and approaches like accelerated approval to advance cell and gene therapies.
Duchenne is characterized by a mutation in the dystrophin gene that results in the lack of dystrophin, which acts as a shock absorber for muscle at the membrane.
SRP-9001 is designed to treat the proximate cause of Duchenne by delivering to the muscle a gene that codes for a shortened, functional form of dystrophin.
Credit Suisse analyst maintains Sarepta Therapeutics with a Neutral rating, lowering the price target from $144 to $139.
Price Action: SRPT shares are down 20.27% at $119.33 on the last check Friday.
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This article Sarepta Plunges As FDA Takes Surprise Turn; AdComm Meeting Set For Duchenne Gene Therapy originally appeared on Benzinga.com
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