The securities law firm Faruqi & Faruqi, LLP is conducting an investigation into potential legal claims against Capricor Therapeutics, Inc. (NASDAQ: CAPR). The firm announced an approaching deadline for investors who experienced losses.
The investigation centers on allegations of false or misleading statements made by Capricor and its executives. These statements, according to the complaint, involved the company’s lead cell therapy candidate, deramiocel, intended for treating cardiomyopathy related to Duchenne muscular dystrophy (DMD). The firm contends that Capricor provided overly positive assessments regarding the drug’s potential and its ability to secure a Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA).
Faruqi & Faruqi, LLP alleges that these positive statements were made while concealing negative information from the four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.
On July 11, 2025, Capricor released a statement that the FDA had issued a Complete Response Letter (CRL), rejecting the BLA. The FDA cited insufficient evidence of effectiveness and the need for additional clinical data. The CRL also pointed to unresolved issues in the Chemistry, Manufacturing, and Controls section of the application.
Following the FDA‘s decision, Capricor‘s stock price fell from $11.40 per share to $7.64 per share.
Faruqi & Faruqi, LLP partner James (Josh) Wilson stated that investors who bought or acquired Capricor securities between October 9, 2024, and July 10, 2025, should contact the firm to discuss their options. The deadline to seek the role of lead plaintiff in the federal securities class action is September 15, 2025.
The lead plaintiff will be the investor with the most significant financial stake in the case, adequately representing the class. Any class member can apply to be lead plaintiff or choose to remain a passive participant. Participation in the case does not affect an investor’s right to any potential recovery.
Faruqi & Faruqi, LLP also invites anyone with relevant information about Capricor‘s conduct to contact the firm, including whistleblowers and former employees. The firm has offices in New York, Pennsylvania, California, and Georgia. It has recovered hundreds of millions of dollars for investors since its founding.
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