More Drama for Sarepta as FDA Delays Duchenne Drug, Shares Tank
Summary
Holding a drug with very promising results—albeit in a small sample size—for a crippling disorder with no cure, the Cambridge, MA-based biotech zoomed up the stock charts.The past year, however, has been a humbling one for Sarepta marked by executive turmoil and today, a delay to its all-important Duchenne Muscular Dystrophy drug candidate, eteplirsen.Sarepta also now has to have a 168-week set of clinical data from the 12-patient study in hand at the time of the NDA submission, as opposed to submitting it while the FDA is already reviewing the application.When asked by analysts what changed between April and now, Garabedian said that one thing the FDA pointed to was a site visit to the Nationwide Children’s Hospital in Columbus, OH, in May.Sarepta appeared to iron its issues out with the agency, but this summer saw the abrupt firing of CSO Art Krieg, the resignation of chairman William Goolsbee, and the release of 144-week data from its small trial that disappointed investors.