Sarepta: FDA To Review BLA For SRP-9001 - Quick Facts

(RTTNews) - Sarepta Therapeutics, Inc. (SRPT) announced the FDA has accepted the company's Biologics License Application seeking accelerated approval of SRP-9001 for the treatment of ambulant individuals with Duchenne muscular dystrophy. SRP-9001 has been granted Priority Review by the FDA, with a regulatory action date of May 29, 2023. The company noted that SRP-9001 would be the first gene therapy for Duchenne.

Sarepta is responsible for global development and manufacturing for SRP-9001. In December 2019, Roche partnered with Sarepta to accelerate access to SRP-9001 for patients outside the United States.

For More Such Health News, visit rttnews.com.