Capricor Therapeutics Inc.
(NASDAQ:CAPR) stock is trading lower on Friday, down by 13%.
The Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) of the U.S.
Food and Drug Administration (FDA) is planning to convene an advisory committee meeting to discuss the company’s Biologics License Application (BLA) seeking approval of Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
Read Also: Capricor Therapeutics Says NS Pharma Delays Could Threaten Access To Duchenne Therapy FDA Sets Advisory Committee Meeting For Capricor Deramiocel The BLA is supported by the Phase 2 HOPE-2 trial and long-term outcomes from the HOPE-2-OLE trial, as well as positive results from the Phase 3 HOPE-3 trial, which achieved statistical significance on its primary endpoint (PUL v2.0), the key secondary cardiac endpoint (LVEF), and all other Type I error-controlled secondary endpoints.
