Sarepta shares drop as report says FDA almost rejected under-review gene therapy

(Reuters) – Sarepta Therapeutics Inc’s shares fell as much as 19.4% premarket on Thursday as Stat News reported that the U.S. Food and Drug Administration’s staff were inclined to reject the company’s gene therapy which is currently under review.

Shares of Catalent Inc, which holds the contract manufacturing rights for the therapy, fell nearly 5% to $61.22 premarket. 

Some staff at the FDA had reached a “non-binding conclusion” that Sarepta’s gene therapy should not be given approval, prompting FDA official Peter Marks to intervene and schedule an advisory meeting instead, Stat News reported, citing sources.

Marks stepped in and directed the agency staff to schedule an advisory panel meet on the therapy on May 12, according to the report.

Sarepta and the FDA did not immediately respond to Reuters requests for comment on the report.

The company’s shares were down 10% at $123.87 in premarket trade on Thursday.

(Reporting by Raghav Mahobe in Bengaluru; Editing by Devika Syamnath)