Capricor Therapeutics Faces Class Action Lawsuit Over Alleged Securities Fraud

In a significant development for investors of Capricor Therapeutics, Inc. (NASDAQ: CAPR), the law firm Hagens Berman has issued a call for those who experienced substantial financial losses to join a class action lawsuit filed against the company. This legal action, now underway, alleges that certain misleading statements made by executives regarding the clinical trial data and regulatory path for their key product, Deramiocel, have caused significant distress among shareholders.

Background of the Case

The core of the lawsuit revolves around the alleged failure of Capricor and its executives to disclose critical information affecting the company's lead product candidate, Deramiocel, designed to treat Duchenne muscular dystrophy (DMD). According to the allegations, material alterations were made to their pre-specified statistical analysis plan (SAP) without proper consent from the U.S. Food and Drug Administration (FDA) prior to the resubmission of their Biologics License Application (BLA). Such changes are said to have potentially misrepresented the efficacy and safety outcomes of Deramiocel, which could have instigated investors' decisions during the contentious market period.

HOPE-3 Trial Announcement and Market Reaction

On December 3, 2025, Capricor staged a major announcement revealing ‘Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy.’ The CEO confidently stated that the trial delivered compelling evidence underscoring the drug’s potential to improve DMD outcomes dramatically. Following these announcements, the stock surged by 370%, indicating investor exuberance and renewed interest in Capricor.

However, this level of optimism was short-lived. The day after the peak in stock price, Capricor proposed a public offering that included six million shares priced at $25 each, banking on the prevailing positive sentiment.

FDA Briefing Document Unveils SAP Changes

Fast forward to July 27, 2026, and the narrative shifted abruptly when the FDA released a briefing document ahead of an important meeting to evaluate Capricor's resubmitted BLA for Deramiocel. To the shock of many, the FDA outlined that, contrary to Capricor's former claims, the HOPE-3 trial did not achieve its primary and secondary efficacy endpoints, displaying no statistically significant differences between Deramiocel and a placebo. These revelations initiated a rapid decline in Capricor’s stock value, plummeting approximately 64% in the wake of the news, with shares closing at just $7.

Moving Forward: Investor Action and Legal Options

For investors impacted by these developments, Hagens Berman encourages those who bought or acquired Capricor securities between December 17, 2025, and July 26, 2026, to consider their legal options. The firm stresses that while one can pursue lead plaintiff status—by the deadline of September 28, 2026—it's not mandatory for participation in potential recovery.

Reed Kathrein, a partner at Hagens Berman, emphasized the necessity of a thorough investigation into how management represented the effectiveness of Deramiocel and the undisclosed modifications to the trial's endpoints. The firm is dedicated to ensuring that investors are informed and supported through the legal process, providing avenues for them to seek justice for their losses.

Whistleblowers or individuals privy to non-public information regarding Capricor's dealings are also encouraged to step forward, considering the potential rewards under the SEC Whistleblower Program for information leading to successful recoveries.

For more information or to discuss potential claims, impacted investors can reach out directly to Hagens Berman through their dedicated resources.

In summary, the unfolding story of Capricor Therapeutics highlights the importance of transparency in communication from corporate entities, especially when it concerns health-related products that significantly affect investors' financial well-being. Stakeholders must be vigilant and aware of the developments, not only to protect their investments but also to support a system that holds companies accountable for their actions.