JonesResearch says CRL would not be end for Capricor’s deramiocel

JonesResearch analyst Catherine Novack says multiple sources have reported that Nicole Verdun, director of Center for Biologics Evaluation and Research’s Office of Therapeutic Products, was placed on leave and is likely being forced out of the FDA by newly appointed CBER director Vinay Prasad. STAT reported that Verdun and Prasad disagreed about Capricor Therapeutics (CAPR)’ application for deramiocel in Duchenne Muscular Dystrophy and anonymous sources said Prasad was skeptical of deramiocel, the analyst tells investors in a research note. The firm spoke with management, and notes they initially believed the deletion was administrative. That said, a complete response letter would “not the end of the road” for deramiocel, and the Phase 3 HOPE-3 study is fully enrolled and would support FDA approval by 2027, contends JonesResearch. The firm notes Capricor has $145M in cash, which provides runway into 2027. The stock in afternoon trading is down 36%, or $4.29, to $7.65.