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Sarepta sinks as FDA changes drug approval rules

Shares of Sarepta Therapeutics fell nearly 26 percent Thursday as the Food and Drug Administration finalized new procedures for expanded access for unapproved drugs.

"Today, the FDA finalized its efforts to streamline the process used by physicians to request expanded access, often called 'compassionate use,' to investigational drugs and biologics for their patients," FDA Commissioner Robert Califf said in a statement.

This move could mean bad news for Sarepta's application for its Duchenne muscular dystrophy drug eteplirsen. The FDA was set to decide on the drug by May 26, but postponed the decision indefinitely.

Analysts were...


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