Shares at Sarepta Therapeutics jump after FDA delay in drug approval review
pharmafile | May 26, 2016 | News story | Research and Development, Sales and Marketing | Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment
Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and Drug Administration (FDA) delayed the completion of its review of the new drug application for Duchenne muscular dystrophy drug, eteplirsen.
The original date for the final FDA decision was set for May 26, but the FDA has now indicated that it will take more time on its review. According to Sarepta, the FDA “has communicated that they will continue to work past the Prescription Drug User Fee Act goal date and strive to complete their work in as timely a manner as possible.”
In April, shares at the company plunged more than 38% after a negative review from staff at the FDA who wrote that: “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.”
The trial data provided only included 12 patients which the FDA raised doubts that it couldn’t provide significant results.
Upon the delayed announcement of this decision, however, shares at Sarepta have rallied, rising over 25% in just under 24 hours. No date has yet been set for the publication of the FDA’s final decision.
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