Sarepta Gets Second Wind, As FDA Delays Drug Decision — Again

By | May 25, 2016

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Biotech Sarepta Therapeutics ( SRPT ) soared in early trading Wednesday after the Food and Drug Administration delayed making a decision on whether to approve its muscular dystrophy drug, giving new hope for a product that Wall Street had generally given low odds. The FDA’s self-imposed deadline had been Thursday, which itself was pushed back three months from the original decision date. Sarepta’s statement didn’t mention a new deadline, just saying that the reviewers “will not be able to complete their work” by the current deadline. Sarepta’s drug eteplirsen, for a subgroup of patients with Duchenne muscular dystrophy (DMD), had always had a tough case to make based on a clinical trial with only 12 subjects and no internal control group. The odds of success looked even lower when the majority of an FDA advisory committee last month voted not to recommend approval. However, families of patients with DMD, who generally don’t live past the age of 30, have been lobbying hard for some treatment to come on the market, since currently none are available. Analyst Simos Simeonidis of RBC Capital Markets suspects that this is the reason for the delay, but he still gives the drug only a 30% chance of approval. “Despite the fact that today’s news slightly increases the chances of an approval, we have a hard time imagining the agency setting the precedent of approving a drug with such a limited dataset,” Simeonidis wrote in a research note. “On the other hand, we cannot overlook the tremendous pressure being put on the FDA, and it is very difficult to gauge what may happen behind the scenes at the agency at the last minute.” Sarepta stock shot up 20% soon after the opening bell on the stock market today , near 22. Scalper1 News

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