Press release
Sarepta Therapeutics Announces that the Date of the Advisory Committee Meeting for SRP-9001 will be May 12, 2023
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced
About this update from Sarepta Therapeutics, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSarepta 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.\n\n\n“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.”\n\n\nAbout SRP-9001 (delandistrogene moxeparvovec)\n\n\nSRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of functional components of dystrophin. Sarepta is responsible for global development and manufacturing for SRP-9001 and plans to commercialize SRP-9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for Duchenne to accelerate access to SRP-9001 for patients outside the United States.\n\n\nAbout Sarepta Therapeutics\n\n\nSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.\n\n\nInternet Posting of Information\n\n\nWe routinely post informatio...