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.
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HHS spokesperson tells Reuters FDA 'actively re-evaluating' Capricor AdCom
Capricor Therapeutics provides regulatory update on Deramiocel BLA
Roth says 'excessive' Capricor selloff due to 'investor overreaction'
Capricor selloff brings buying opportunity, says H.C. Wainwright
Capricor Therapeutics price target lowered to $22 from $43 at Oppenheimer
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