Sarepta Therapeutics
‘ stock was plummeting after the Food and Drug Administration said it is seeking input from a panel of independent experts on the biotech’s new gene-therapy drug, but analysts remained bullish, calling the update “surprising,” but not negative.
It was only about two weeks ago that Sarepta said that the FDA has no plans to hold an advisory committee meeting to evaluate SRP-9001 for treating Duchenne muscular dystrophy, a genetic disorder. But Thursday in a call with analysts, Sarepta said the FDA changed its decision as SRP-9001 is one of the first gene-therapies biologics license applications founded on a surrogate endpoint—a substitute to clinical outcomes.
Source: https://www.barrons.com/articles/sarepta-therapeutics-stock-fda-8efe821b?siteid=yhoof2&yptr=yahoo