Shares of the rare disease juggernaut Sarepta Therapeutics (NASDAQ: SRPT) fell by 12.6% through the first three and a half days of trading this week, according to data provided by S&P Global Market Intelligence. The biotech's stock fell almost on cue ahead of the upcoming advisory committee meeting this Friday for its Duchenne muscular dystrophy (DMD) gene therapy known as SRP-9001.  

It's almost tradition at this point for smaller companies with high-value product candidates to dip ahead of an advisory committee meeting. The key reason is that the Food and Drug Administration (FDA) releases what are known as "briefing documents" prior to the meeting. These briefing documents tend to point out weaknesses in the regulatory filing, which then become important topics for the panel of experts to mull over during the meeting.

In this case, the briefing documents called SRP-9001's efficacy into question and raised safety concerns regarding the administration of a potentially ineffective gene therapy. Now, investors clearly shouldn't brush off these concerns as standard operating procedure for the FDA. The FDA, after all, has become considerably more strict in recent years, especially in regard to cutting-edge therapies like SRP-9001.

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Source Fool.com