Broad label for Sarepta’s Elevidys as prospects dim for a second DMD gene therapy

FDA’s decision to grant full approval and expand the label of Sarepta’s DMD gene therapy establishes the product’s microdystrophin expression levels as the benchmark to beat for the next gene therapies. The outstanding question, however, is how much microdystrophin was induced by Pfizer’s gene therapy. If it was similar, the picture could get complicated.

In all events, the recent Phase III failure of DMD gene therapy from Pfizer Inc. (NYSE:PFE) dims the debate about whether treating patients with the product from Sarepta Therapeutics Inc. (NASDAQ:SRPT) will prevent them from receiving a better, next-generation therapy — there’s no longer another candidate on the near-term horizon. ...