Sarepta's Roller Coaster Hits a High Point

Let's hope Sarepta Therapeutics doesn't follow in Prosensa and GlaxoSmithKline's footsteps and come crashing down.

Brian Orelli
Brian Orelli
Apr 22, 2014 at 9:30AM
Health Care

Sarepta Therapeutics (NASDAQ:SRPT) has been on a roller coaster over the last few months with the Food and Drug Administration telling the company last November that it had concerns about granting an accelerated approval for Sarepta's muscular dystrophy drug eteplirsen.

The decision wasn't a big surprise after Prosensa (UNKNOWN:RNA.DL) and GlaxoSmithKline's (NYSE:GSK) related drug, drisapersen, failed its phase 3 trial last year.

Then Monday, the agency did a bit of a 180, saying that there might be enough data to approve eteplirsen, encouraging Sarepta to apply for accelerated approval.

In the video below, senior biotech specialist Brian Orelli and health-care bureau chief Max Macaluso discuss the potential paths forward for Sarepta and its chances of gaining accelerated approval.