Capricor Therapeutics Inc Securities Lawsuit Investigation

Shamis & Gentile P.A., one of the nation's premier class action law firms specializing in securities fraud cases, is investigating potential claims against Capricor Therapeutics Inc. (CAPR).

If you purchased or held Capricor Therapeutics Inc securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Capricor Therapeutics Inc

Capricor Therapeutics Inc, listed on the Nasdaq, is a biotechnology company focused on developing therapies for rare diseases, with a primary emphasis on neuromuscular and cardiovascular disorders. The company’s lead program has been deramiocel, a cell therapy developed for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Capricor has highlighted deramiocel as its “core program,” frequently describing it as a first-in-class therapy and emphasizing its potential to transform the treatment landscape for DMD.

The Allegations

The investigation centers on whether Capricor Therapeutics and its top executives misled investors about the prospects and regulatory status of deramiocel, resulting in significant financial harm when the truth emerged.

Capricor’s public communications repeatedly portrayed deramiocel as likely to receive FDA approval and in good regulatory standing. For example, on March 4, 2025, the company announced that the FDA had accepted its Biologics License Application (BLA) for deramiocel, assigning a PDUFA date of Aug. 31, 2025, and stated that “at this time, FDA has not identified any potential review issues” alluding to no foreseeable problems. However, the FDA ultimately rejected the application, citing efficacy and manufacturing concerns that had not been previously disclosed contradicting Capricor’s narrative.

On May 5, 2025, Capricor reported that after its mid-cycle review meeting, the FDA noted “no significant deficiencies” and that the BLA remained “on track” for the August 31 target date implying the application was in good shape. In the same release, the CEO praised these milestones. Yet, the FDA’s later complete response letter revealed that clinical data were insufficient and that manufacturing issues existed contradicting these optimistic statements.

Capricor also issued regulatory updates in its first quarter 2025 results, reiterating the August 31 PDUFA date and stating that the FDA had completed a facility inspection without material issues and planned to convene an advisory committee suggesting a smooth path to approval. The company claimed its facility met requirements for approval while omitting that the FDA had observed manufacturing deficiencies. These optimistic statements failed to disclose adverse information that the FDA ultimately cited in its rejection.

In SEC filings and public statements, Capricor’s executives emphasized that deramiocel was progressing and highlighted positive trial results without disclosing the application’s weaknesses and the lack of convincing efficacy data. The company failed to mention any known FDA concerns prior to the July decision, potentially leaving investors with the impression that the review was free of problems. This omission became significant when the FDA’s complete response letter on July 11, 2025, revealed that the data “did not demonstrate” efficacy and that the agency “could not review” the manufacturing section fully disclosing the key facts investors had been misled about.

The impact on investors was immediate and severe. On July 11, 2025, following the FDA’s decision, Capricor’s stock plunged approximately 30%, closing at around $7.64 (down from roughly $10.94 the previous trading day), wiping out about $150 million in market capitalization given the roughly 46 million shares outstanding at the time. Earlier, on May 5, 2025, the stock had already fallen nearly 15% after Capricor announced the FDA would convene an advisory panel for deramiocel, reflecting growing regulatory uncertainty.

Evidence suggests that Capricor’s management was aware, or was perhaps reckless in not knowing, that their statements were misleading. The company had strong financial motives, including a recent $75 million stock offering and lucrative distribution agreements that depended on regulatory success. Deramiocel was the company’s core business, and top executives, including CEO Linda Marbán, were closely involved in its development and regulatory strategy. The contrast between Capricor’s optimistic public statements and the FDA’s ultimate findings supports a strong inference of scienter.

Your Rights and Next Steps

This is an active investigation into potential securities fraud at Capricor Therapeutics Inc., and no lawsuit has been filed at this stage. If the investigation uncovers evidence of wrongdoing, it may lead to a class action lawsuit on behalf of investors who suffered losses.

Investors who purchased or held Capricor securities between September 24, 2024, and July 11, 2025, and experienced financial losses tied to the company’s alleged misstatements or omissions may have legal options.

By joining the investigation, investors can help lawyers assess the full impact of the alleged fraud and strengthen any potential case. Participation is confidential, and there is no cost or obligation to be part of the investigation.

Lawyers are ready to help investors understand their rights, gather relevant documentation, and determine eligibility for any future class action. If a lawsuit is filed, eligible investors may be able to recover a portion of their losses if the case is successful.

You May Be Entitled to Compensation

To participate in the investigation or learn more about your legal options, complete the below form. Lawyers are available to answer questions and guide you through the process.