According to the company, it plans to seek a Biologics License Application (BLA) for accelerated approval of SRP-9001 from the U.S. Food and Drug Administration (FDA). Sarepta Therapeutics is developing this gene therapy alongside Roche.
This follows up an in-depth review of the treatment after it was granted Fast Track status by the FDA back in 2020. The gene therapy also has a Rare Pediatric Disease (RPD) designation in the U.S., as well as Orphan Drug status in the U.S., E.U., Switzerland, and Japan.
Doug Ingram, president and CEO of Sarepta Therapeutics, said the following about the news:
We look forward to a collaborative review commencing this year and running through the first half of 2023. Duchenne robs children daily and hourly of their muscle, stealing them bit by bit from their families and loved ones. Guided by rigorous science and productive regulatory discussions, our goal is to move with the urgency desperately needed by the patient community, and our upcoming BLA filing for SRP-9001 serves that goal.
SRPT stock is seeing heavy trading today with more than 1.5 million shares on the move as of this writing. To put that in perspective, the company’s daily average trading volume is about 795,000 shares.
SRPT stock is up 5.1% as of Friday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.