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Important Updates for Capricor Therapeutics Investors Amid Class Action Lawsuit

On September 9, 2026, Levi & Korsinsky, LLP has alerted investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) that a class action has been initiated on behalf of shareholders who purchased securities during the specified class period crucial for active participation. This period extends from December 17, 2025, to July 26, 2026. The lawsuit addresses concerns raised regarding alleged misleading statements made by Capricor, particularly relating to their clinical trial data and resultant stock performance.

Details of the Class Action

The crux of the securities class action revolves around claims that Capricor Therapeutics presented results from its Phase 3 HOPE-3 study in a light that suggested significant statistical achievements. However, it is alleged that crucial details were omitted, notably a last-minute amendment to the statistical analysis plan made just a day before the trial's results were disclosed. The absence of adherence to FDA's agreed protocols raises grave concerns about the integrity of the reported trial outcomes.

As reported, the share price of CAPR was $19.70 on July 24, 2026, but faced a dramatic downturn shortly thereafter. The stock plummeted by approximately 78.7%, with substantial corrective negative disclosures revealing significant discrepancies in the initial reporting and the actual findings endorsed by the FDA. On July 27, the FDA briefing documents contradicted Capricor’s prior claims, stating that the trial had not met its prescribed efficacy endpoints, which contributed heavily to the stock's loss, dropping to $7.00 at one point.

Timeline of Key Events

The allegations are underscored by a chronological sequence detailing the company’s communication with investors:

• - November 24, 2025: The final version of the statistical analysis plan is dated just prior to the unblinding of the results, and this document was never reviewed by the FDA.
• - December 17, 2025: Capricor declares the beginning of the class period while discussing the HOPE-3 results, claiming the endpoints were statistically significant.
• - January 20, 2026: A regulatory update suggests significant advancements in both cardiac and skeletal muscle functions based on the HOPE-3 results.
• - March 10, 2026: Announcement of the FDA lifting a Complete Response Letter, providing hope to investors with announcements of an impending PDUFA action date set for August 22, 2026.
• - July 27, 2026: Disclosures from the FDA contradict previously made claims regarding study effectiveness, ushering in an avalanche of negative investor sentiment and resulting in a drastic fall in stock price.

Implications for Shareholders

The lawsuit poses significant implications for shareholders who sustained losses due to what is alleged as a lack of transparency by Capricor. Legal representatives highlight that material disclosures of pivotal developments are essential in ensuring fair and efficient markets. The lawsuit raises queries about when Capricor's internal team became aware of the unrecognized changes to the statistical analysis plan yet failed to timely inform their investors.

Investors are encouraged to gather pertinent brokerage documentation including purchase dates and quantities as the lead plaintiff status can crucially impact the lawsuit proceedings. The deadline for seeking the lead plaintiff status is set for September 28, 2026.

Frequently Asked Questions

How Much Did CAPR Stock Drop?

According to the lawsuit, shares fell drastically by nearly $15.08 per share in the wake of corrective disclosures.

What Specific Misstatements Were Alleged?

The allegations point towards misleading statements regarding the statistical significance of HOPE-3 results focusing on the strength of the submitted Biological License Application (BLA).

What is the Next Step for CAPR Investors?

Investors need to contact Levi & Korsinsky for a complimentary assessment to explore their potential eligibility for compensation.

Investors who traded in CAPR during the highlighted class period are urged to assess their losses related to these events. They may still be eligible to seek recovery, even if shares have since been sold. In securities class actions, plaintiffs are generally represented without upfront costs, aligning compensations with recovery outcomes legalized in court.

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For more information and assistance, you can reach out to Joseph E. Levi, Esq. at Levi & Korsinsky, LLP.

Contact Details:
Tel: (212) 363-7500
Email: [email protected]

Stay updated and alert regarding the progress of this significant lawsuit affecting many investors closely tied with the Capricor Therapeutics’ stock status.