Sarepta drops as report says FDA almost rejected under-review gene therapy
Sarepta drops as report says FDA almost rejected under-review gene therapy
April 13 (Reuters) – Sarepta Therapeutics Inc.’s shares (SRPT.O) fell more than 6% on Thursday as Stat News reported that the U.S. health regulator’s staff were inclined to reject the company’s gene therapy which is currently under review.
Some staff at the U.S. Food and Drug Administration (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 instead schedule an advisory meeting on May 12, Stat News reported, citing sources.
Baird said in a note that while the report “does create drama” around the May 12 panel meet, support from Mark “ultimately favors the odds of accelerated approval going through”.
The company is seeking approval for its gene therapy for treating a rare muscle-wasting disorder called Duchenne muscular dystrophy under the FDA’s accelerated pathway.
When asked for a statement on the news, the FDA said it cannot comment on unapproved products, including its review of any applications that may be pending. Sarepta did not respond to a Reuters request for comment.
Brokerage William Blair said it still sees a “likely” approval for the therapy.
Shares of Catalent Inc. (CTLT.N), which holds the contract manufacturing rights for the therapy, fell as much as 5.5% in early trade.
“The approval has been viewed as a meaningful catalyst to drive revenue upside” for Catalent, J.P. Morgan analyst Julia Qin said.
Sarepta’s shares were down 6.2% at $129.09.
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