ARTICLE | Clinical News

FDA to allow limb function endpoint in Capricor's DMD trials

July 28, 2017 12:10 AM UTC

Capricor Therapeutics Inc. (NASDAQ:CAPR) jumped $0.29 (29%) to $1.30 on Thursday after saying it received minutes from an FDA meeting indicating the agency’s “willingness to accept" the Performance of the Upper Limb (PUL) outcome measure as a BLA-supportive primary efficacy endpoint in trials of Duchenne muscular dystrophy candidate CAP-1002. This half, the company plans to start a Phase II trial of IV CAP-1002.

PUL is an instrument that measures patients' upper limb function at three levels -- the shoulder, elbow, and wrist and fingers -- while performing tasks such as weighted and unweighted movements, gripping and fine motor tasks, including picking up coins and tracing a path...