Capricor’s deramiocel moves ahead without AdCom, says H.C. Wainwright

Capricor on Tuesday disclosed that the FDA has indicated that no AdCom is necessary for deramiocel’s Biologics License Application, and an in-person late-cycle review meeting is scheduled for mid-July, H.C. Wainwright analyst Joseph Pantginis tells investors in a research note. The firm, which has a Buy rating and $77 price target on the shares, highlights that even in bear case scenarios with the FDA, Phase 3 HOPE-3 data readouts are “waiting in the wings” to further strengthen deramiocel’s overall clinical and regulatory package and thinks deramiocel’s first-in-class therapeutic profile in tandem with strong manufacturing support will get the therapy over the finish line on expected timelines.