#USA #New York #Class Action #Pomerantz LLP #Capricor Therapeutics

Pomerantz Law Firm's Investor Alert

Pomerantz LLP recently announced that a class action lawsuit has been launched against Capricor Therapeutics, Inc. (NASDAQ: CAPR), on behalf of investors who suffered losses due to alleged securities fraud and other unlawful business practices. Investors are urged to contact Danielle Peyton at Pomerantz for more information and guidance on how to join the class action, especially those who purchased shares within the defined class period. The deadline to potentially become a Lead Plaintiff is September 28, 2026.

Background of Capricor Therapeutics

Capricor Therapeutics, based in California, has been under scrutiny after its Biologics License Application (BLA) for Deramiocel—a cell therapy for Duchenne muscular dystrophy—encountered major challenges with the U.S. Food and Drug Administration (FDA). In late 2024, Capricor submitted this application, but by July 2025, the FDA issued a Complete Response Letter, indicating the BLA did not meet the necessary requirements for effectiveness, requesting additional clinical data and evidence.

Issues with FDA Approval

In March 2026, Capricor asserted that they had rectified the issues pointed out by the FDA in its previous response. However, ahead of a critical advisory committee meeting in July 2026, the FDA released briefing documents highlighting significant concerns regarding the pre-specified statistical analysis plan (SAP). It was revealed that changes made to this plan were not properly consented or agreed upon by the FDA before the BLA submission, which raised questions regarding the scientific validity of the efficacy results presented by Capricor. The FDA deemed the analyses performed as post-hoc and exploratory, ultimately leading to an unfavorable benefit-risk assessment for Deramiocel.

Impact on Stock Price

The fallout from the FDA briefing documents had an immediate and severe impact on Capricor's stock performance. On July 27, 2026, the stock price plunged by $12.70 (64%) to close at $7.00 per share. Subsequent meetings and panels only compounded negative sentiment; an advisory committee voted against the efficacy of Deramiocel, resulting in further share price declines, closing at $4.19 per share—down $2.38 (36%) on July 30.

Role of Pomerantz LLP

Pomerantz LLP, a leading figure in securities class action litigation, plays a critical role in protecting the rights of investors experiencing losses due to fraud and corporate misconduct. With an extensive history of recovering damages for affected shareholders, the firm is proceeding with its investigation concerning Capricor's actions and advising previous investors on the potential next steps, including how to join the class action lawsuit.

Conclusion

This situation surrounding Capricor Therapeutics underscores the importance of corporate accountability and investor awareness. As the deadline to join the plaintiffs approaches, affected investors are encouraged to seek legal assistance and participate in the class action to secure their rights and potentially recover their losses. Investors should consider the potential implications of these ongoing legal proceedings when evaluating their investments in Capricor and weigh their options carefully. For more information on how to proceed, reach out to Pomerantz LLP's dedicated contact.

For further updates and details regarding the lawsuit, interested parties can visit Pomerantz LLP's website.