
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Capricor Therapeutics, Inc. due to allegations of violations of federal securities laws related to misleading statements about its lead drug candidate, deramiocel, and its regulatory status with the FDA [3][5]. Group 1: Legal Investigation and Claims - Faruqi & Faruqi is encouraging investors who suffered losses exceeding $50,000 in Capricor between October 9, 2024, and July 10, 2025, to discuss their legal options [1]. - A federal securities class action has been filed against Capricor, with a deadline of September 15, 2025, for investors to seek the role of lead plaintiff [3][8]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [4]. Group 2: Allegations Against Capricor - The complaint alleges that Capricor and its executives made false and misleading statements regarding the drug deramiocel, particularly concerning its ability to obtain a Biologics License Application (BLA) from the FDA [5]. - The allegations include concealing adverse facts about the four-year safety and efficacy data from the Phase 2 HOPE-2 trial of deramiocel [5]. Group 3: 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 [6]. - 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 [7].