Capricor share weakness unwarranted, says H.C. Wainwright

H.C. Wainwright analyst Joseph Pantginis views the weakness in shares of Capricor Therapeutics (CAPR) after the company announced the completion of a mid-cycle review meeting with the FDA as unwarranted. The FDA stated no significant deficiencies were identified by the Review Committee, and deramiocel’s package is on track for the previously announced action date of August 31, but the FDA also communicated it plans to hold an advisory committee meeting, although an official date has not yet been set, the analyst tells investors in a research note. The firm believes the totality of deramiocel’s data collected by Capricor “stands for itself.” Given the opportunity to present at the panel meeting, the company is likely to strengthen the therapy’s petition by highlighting the high unmet need for new therapies in the Duchenne muscular dystrophy space, and deramiocel’s positive novelty, safety, and efficacy, contends H.C. Wainwright. It believes deramiocel remains on track to be approved with the requested label. H.C. Wainwright keeps a Buy rating on the shares with a $77 price target The stock in morning trading is down 10% to $10.71.