By Senad Karaahmetovic
Shares of Sarepta Therapeutics (NASDAQ:SRPT) are down about 10% in pre-market Thursday following a report that said the U.S. Food and Administration (FDA) staff leaned toward rejecting the company’s Duchenne muscular dystrophy gene therapy before a senior official intervened.
Stat News reported that initial consideration from FDA staff prompted Peter Marks, a top official at FDA, to intervene twice earlier this year in relation to the closely-watched gene therapy for Duchenne muscular dystrophy.
Accordingly, some staff members “had reached a non-binding conclusion that Sarepta’s gene therapy should be rejected,” Stat News reported citing three people with direct knowledge of the agency deliberations. The staff didn’t think the therapy meets the criteria for accelerated approval.
However, Peter Marks ordered staff to schedule a public hearing on the therapy on May 12. Sarepta confirmed the advisory committee meeting on this date earlier this week.
“We look forward to sharing the wealth of evidence supporting the transformative potential of SRP-9001 for the treatment of Duchenne muscular dystrophy with the advisory committee on May 12, 2023,” said Doug Ingram, president and chief executive officer, Sarepta.
“We would again like to thank Center for Biologics Evaluation and Research and the Office of Therapeutic Products for working swiftly to schedule the advisory committee in advance of our regulatory action date of May 29, 2023.”
Marks is the current Director of the Center for Biologics Evaluation and Research (CBER).
SRPT shares are up 6.2% YTD.