Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are trading lower Thursday on the heels of a report suggesting some U.S. Food and Drug Administration staff had opposition towards Sarepta gene therapy before a top official intervened.
What Happened: According to a Stat News report citing three people with direct knowledge of the deliberations, reviewers at the FDA initially favored rejecting Sarepta’s gene therapy for Duchenne muscular dystrophy before one of the FDA’s top officials stepped in and directed staff members to set a public hearing for the therapy.
The report indicates that the FDA official, Peter Marks, is well known as an advocate for faster gene therapy approvals.
Sarepta aims to engineer precision genetic medicine for rare diseases. The company focuses on Duchenne muscular dystrophy and limb-girdle muscular dystrophies and currently has more than 40 programs in various stages of development.
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SRPT Price Action: Sarepta has a 52-week high of $159.83 and a 52-week low of $61.30.
The stock was down 10.2% at $123.69 at time of publication, according to Benzinga Pro.
Photo: felixioncool from Pixabay.
