FDA lifted its Complete Response Letter and resumed review of Capricor Therapeutics' Biologics License Application seeking full approval of Deramiocel, removing a key regulatory hurdle. The development materially improves the company's regulatory outlook and could drive a multi-percent move in the stock pending further review milestones or an approval decision.
FDA lifted its Complete Response Letter and resumed review of Capricor Therapeutics' Biologics License Application seeking full approval of Deramiocel, removing a key regulatory hurdle. The development materially improves the company's regulatory outlook and could drive a multi-percent move in the stock pending further review milestones or an approval decision.
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