CAPR Investors Have the Opportunity to Lead the Capricor Therapeutics Securities Fraud Lawsuit with Faruqi & Faruqi, LLP

Core Viewpoint - Capricor Therapeutics, Inc. is facing a federal securities class action lawsuit due to allegations of misleading statements regarding its lead drug candidate, deramiocel, and its failure to disclose critical safety and efficacy data [4][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against Capricor and has set a deadline of September 15, 2025, for investors to seek the role of lead plaintiff in the class action [4]. - The lawsuit alleges that Capricor and its executives violated federal securities laws by making false statements about the company's ability to obtain a Biologics License Application (BLA) for deramiocel [6]. - The complaint highlights that Capricor provided investors with overly positive statements while concealing material adverse facts regarding the drug's safety and efficacy data from its Phase 2 HOPE-2 trial [6]. Group 2: Regulatory Developments - 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 [7]. - The CRL also pointed out outstanding issues in the Chemistry, Manufacturing, and Controls section of the application [7]. Group 3: Stock Market Reaction - Following the announcement of the CRL, Capricor's stock price fell 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 [8].