Will Sarepta’s confirmatory misses test FDA’s resolve on clinical outcomes?

Sarepta has failed to demonstrate clinical benefit of two exon-skipping therapies for Duchenne muscular dystrophy in a confirmatory trial, adding to the body of evidence suggesting DMD drugs on the market may be doing little to improve how patients move and function — at least at the population level.

How FDA handles this case could be another indicator of how stringent the new leadership will be on clinical outcomes requirements. Past leaders have often seemed to make exceptions for DMD therapies from Sarepta Therapeutics Inc. (NASDAQ:SRPT)...