Sarepta: Duchenne AdComm May 12

  Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the date of the U.S. Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA) is May 12, 2023. The advisory committee meeting will be hosted as a virtual meeting. SRP-9001 is Sarepta’s investigational gene therapy for the treatment of Duchenne muscular dystrophy.

“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.”

https://www.biospace.com/article/releases/sarepta-therapeutics-announces-that-the-date-of-the-advisory-committee-meeting-for-srp-9001-will-be-may-12-2023/