Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least an­tic­i­pat­ed moves of the year, the FDA has re­ject­ed Sarep­ta’s ap­pli­ca­tion for an ac­cel­er­at­ed ap­proval of its Duchenne MD drug golodirsen af­ter fret­ting over safe­ty is­sues.

In a state­ment that ar­rived af­ter the bell on Mon­day, Sarep­ta ex­plained the CRL, say­ing:

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.