Shares plunge at Sarepta after negative FDA review on muscle disorder drug

pharmafile | April 21, 2016 | News story | Research and Development, Sales and Marketing |  FDA, Sarepta Therapeutics, Shares, dive, fall, negative, plunge, sarepta 

Sarepta Therapeutics (NASDAQ: SPRT) is counting the cost as shares plunge following a negative review given by staff at the FDA to its muscle disorder drug, eteplirsen.

Officials from the FDA reiterated their concerns over the drug intended to treat a subset of patients with Duchenne muscular dystrophy (DMD). Sarepta had been asked to provide additional information to the FDA and, although shares rose on the news of its further consideration, they have plummeted rapidly on this latest news from the FDA.

In their determination, staff at the FDA wrote: “The data overall did not provide statistical evidence to support the efficacy in subjects who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.” In short, they concluded that the drug was not as efficacious as it should be to warrant approval.

At the time of writing, Sarepta’s share price had fallen 38%.

Sean Murray