Sarepta Therapeutics Inc Q4 2022 Earnings Call Summary

Edited Brief of SRPT.OQ earnings conference call or presentation 28-Feb-23 9:30pm GMT

...A. Overview: 2023 may be the most eventful year in Co.'s event-filled history. 1. 2. Biologics License Application (BLA) for gene therapy SRP-9001 for Duchenne muscular dystrophy will be a significant bellwether moment for: a. Duchenne families who are waiting without luxury of patients for a therapy that might arrest brutal decline associated with this disease. b. Promise of gene therapy as a class to deliver meaningful improvements in lives of patients with rare degenerative diseases, not as some distant vanishing point in future, but in time to do good now. B. SRP-9001 BLA Review: In fall of last year, submitted BLA for SRP-9001 to treat ambulant Duchenne patients. 1. 2. In 4Q, FDA accepted BLA for filing, granted SRP-9001 Priority Review and set 05/29/23 as action date. 3. Has been diligently prosecuting BLA. Has by now completed a productive mid-cycle review with division. a. 4. At mid-cycle, division requested additional CMC information and Co. has by now provided answers to all those...

Brief