Sarepta sinks after STAT says FDA leaned against gene therapy approval

Reviewers at the Food and Drug Administration were leaning toward rejecting Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, prompting a top official to intervene earlier this year, Adam Feuerstein and Jason Mast of STAT report, citing three people with direct knowledge of the agency deliberations. Some FDA staff had reached a non-binding conclusion that Sarepta’s gene therapy should be rejected, sources told STAT. FDA official Peter Marks then stepped in and directed staff to schedule a public hearing, they added. Shares of Sarepta are down 11% to $122.43 in premarket trading while Catalent (CTLT), which has a commercial supply agreement for the gene therapy candidate, is down 5% to $61.00. Reference Link