Capricor CRL breaks with FDA’s pattern of regulatory flexibility in DMD

The complete response letter for Capricor’s deramiocel suggests a break in a long chain of controversial decisions in which FDA has invoked regulatory flexibility in approving products for Duchenne muscular dystrophy.

Capricor Therapeutics Inc. (NASDAQ:CAPR) said early Friday that FDA had issued the CRL due to a belief that the company’s BLA “does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.” The letter also named “certain outstanding items” relating to CMC...