Capricor Therapeutics(US:CAPR) Prnewswireยท2025-09-11 12:45Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to allegations of misleading investors regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2]. Summary by Relevant Sections Allegations - The complaint claims that Capricor provided investors with overly positive information about deramiocel's potential to obtain a Biologics License Application (BLA) from the FDA while concealing adverse facts about its safety and efficacy data from the Phase 2 HOPE-2 trial [1]. - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and the need for additional clinical data [1]. Stock Price Impact - Following the announcement of the CRL, Capricor's stock price dropped from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, reflecting a significant decline in investor confidence [1]. Class Action Details - Shareholders who purchased shares during the class period from October 9, 2024, to July 10, 2025, are encouraged to register for the class action, with a deadline for lead plaintiff appointment set for September 15, 2025 [2]. - Participants will be enrolled in a portfolio monitoring system to receive updates on the case [2]. Law Firm's Mission - The Gross Law Firm aims to protect investors' rights and ensure companies adhere to responsible business practices, seeking recovery for losses incurred due to misleading statements or omissions by companies [3].