Sarepta Tumbles as FDA Delays Duchenne Gene Therapy Decision
The Sarepta Therapeutics Inc headquarters in Boston, US.
Source: Dylan Bauer/Sarepta Therapeutics Inc.
Sarepta Therapeutics Inc. shares fell the most in a month after the US Food and Drug Administration delayed its decision on the company’s gene therapy for Duchenne muscular dystrophy and said it was leaning toward clearing it for only for a subset of younger kids with the disease.
The FDA told Sarepta it needs more time to complete its review, including to negotiate the label for the drug and post-marketing commitments, according to a statement from the company Wednesday. The agency is now expected to rule on the application by June 22; it had been scheduled to make its decision by May 29. The shares fell as much as 10% at the New York market open, the most intraday since April 13.