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.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CAPR:
- 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