Important Update for Capricor Investors Ahead of September 28, 2026 Deadline

Important Notice for Capricor Investors

Faruqi & Faruqi, LLP, a prominent national securities law firm, is currently investigating potential legal claims against Capricor Therapeutics, Inc. The firm is urging investors who suffered losses to pay attention to the forthcoming deadline of September 28, 2026, to participate as a lead plaintiff in a federal securities class action lawsuit against the company.

This legal action focuses on the allegations that Capricor Therapeutics and its executives made false or misleading statements regarding the company’s therapy for Duchenne muscular dystrophy, named Deramiocel. Recent developments have highlighted serious concerns surrounding the regulatory approval process of this therapy, which have had immediate and drastic financial implications for investors.

The crux of the allegations against Capricor involves significant omissions related to the company's practices in changing its pre-specified statistical analysis plan prior to the resubmission of its Biologics License Application (BLA) for Deramiocel. Notably, the complaint states that the company did not secure prior agreement from the FDA regarding these changes, thereby increasing the risks of negative outcomes in the drug's approval process. According to the lawsuit, this led to misleading statements by Capricor about the efficacy and prospects of Deramiocel, which resulted in investor losses following adverse FDA feedback.

On July 27, 2026, prior to the stock market opening, the FDA released briefing documents that stated, “the benefit-risk assessment for Deramiocel appears unfavorable in the absence of evidence of effectiveness.” In response to this critical announcement, Capricor’s stock plummeted by approximately 64%, closing at $7.00 per share amid unusually heavy trading. The situation worsened on July 30, 2026, when the AdCom panel non-bindingly voted 9-3 against the efficacy of Deramiocel, causing the stock to fall another 36%, closing at $4.19 per share.

These significant drops underline the volatile nature of investments in Capricor—especially against the backdrop of the FDA's concerning assessments surrounding their product. Investors who purchased or otherwise acquired Capricor securities from December 17, 2025, to July 26, 2026, are encouraged to scrutinize their investment activities. They may be eligible to join the class action and share in any recoveries resulting from this litigation.

Faruqi & Faruqi, LLP has a track record of recovering significant sums for investors and has been instrumental in guiding them through the often-complex landscape of securities litigation. For potential claimants, the firm stresses the importance of preserving records such as trade confirmations, account statements, and other communications regarding Capricor investments.

The firm invites any investor who may be affected to reach out for an assessment of their potential legal rights and options. This consultation entails no cost and does not obligate the investor to act, yet it might provide invaluable clarity in light of the rapidly approaching September 28, 2026, deadline.

Conclusion

As the situation surrounding Capricor Therapeutics develops, it is essential for affected investors to remain vigilant and informed. The opportunity to step forward as a lead plaintiff or simply to participate in the class action could have significant implications for those financially impacted by the company's alleged misconduct.

For further information regarding this case or to discuss your legal options, please contact Faruqi & Faruqi, LLP at 877-247-4292 or visit their website at www.faruqilaw.com/CAPR. Keeping abreast of developments in this class action will be crucial for every investor involved as the deadline approaches.