FDA does not require AdCom for Capricor's deramiocel, expecting Phase 3 data to strengthen approval.

From Yahoo Finance: 2025-06-25 11:05:00

The FDA indicated no AdCom needed for Capricor’s deramiocel, with a late-cycle review meeting set for mid-July. H.C. Wainwright analyst expects Phase 3 HOPE-3 data to strengthen deramiocel’s regulatory package, confident in its first-in-class therapeutic profile and manufacturing support to meet expected timelines. Firm has Buy rating, $77 price target.

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Read more at Yahoo Finance: Capricor’s deramiocel moves ahead without AdCom, says H.C. Wainwright