BUZZ-Capricor tumbles as FDA panel meet for Duchenne cell therapy adds risk worries
Capricor Therapeutics, Inc. CAPR | 0.00 |
** Shares of Capricor Therapeutics CAPR.O slump 14% to $26.17
** Capricor says the U.S. FDA will hold an advisory committee meeting on July 29 to review its cell therapy, deramiocel, to treat cardiomyopathy in patients with Duchenne muscular dystrophy, a genetic disorder
** The stock reaction reflects "incremental regulatory risk" tied to advisory panels says B. Riley Securities analyst Madison El-Saadi
** FDA last year declined to approve the drug, citing lack of efficacy data and asked for more data
** Capricor said in December that in a late-stage trial deramiocel significantly slowed the decline in muscle and heart function in patients compared to placebo
** El-Saadi says the advisory committee is "not surprising" and focus should be on strength of data
** The FDA decision on the application is expected by August 22
** Including session's move, stock down 10% YTD
