Capricor Therapeutics, Inc. Class Action Lawsuit - CAPR

The filed complaint alleges that Capricor Therapeutics, Inc made materially false and/or misleading statements and/or failed to disclose that: (1) the Company adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for it's lead product candidate, Deramiocel; (2) the FDA had not agreed to those changes before the Company resubmitted the Deramiocel BLA; (3) as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; (4) as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy; and (5) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

In order to be eligible to join the CAPR class action lawsuit, you must have incurred a loss on shares of Capricor Therapeutics, Inc. purchased during the class period listed above.

If you suffered a loss in Capricor Therapeutics, Inc. during the relevant time frame or pursuant to the relevant offering(s), you have until September 28, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Key Facts About Capricor Therapeutics, Inc. (NASDAQ: CAPR)

●       The Allegation: The complaint alleges Capricor Therapeutics, Inc. misled investors about Deramiocel's regulatory prospects by emphasizing statistically significant HOPE-3 results while failing to disclose changes to the pre-specified statistical analysis plan used to analyze clinical data.

●       The Stock Drop: CAPR fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, after FDA briefing documents questioned the company's statistical analyses and stated the benefit-risk assessment appeared unfavorable; CAPR later fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026, after Medscape reported the FDA advisory committee issued a non-binding 9-3 vote concluding that the evidence did not support Deramiocel's efficacy.

●       Class Period & Defendants: The class period runs from December 17, 2025 through July 26, 2026, inclusive. Defendants are Capricor Therapeutics, Inc., Linda Marban, Chief Executive Officer at all relevant times, and Anthony J. Bergmann, Chief Financial Officer at all relevant times.

●       Lead Plaintiff Deadline: September 28, 2026. Investors who wish to seek appointment as lead plaintiff must apply by the deadline. 

Capricor Therapeutics Class Action Summary
Company	Capricor Therapeutics, Inc. (NASDAQ: CAPR)
Lead Plaintiff Deadline	September 28, 2026
Class Period	December 17, 2025 - July 26, 2026
Stock Drop	July 27, 2026 - CAPR fell $12.70 (64%) to $7.00; July 30, 2026 - CAPR fell $2.38 (36%) to $4.19

Introduction

A securities class action lawsuit has been filed against Capricor Therapeutics, Inc. The case covers investors who purchased Capricor securities from December 17, 2025 through July 26, 2026.

The complaint alleges defendants made materially false and misleading statements about Deramiocel, Capricor's Duchenne muscular dystrophy therapy. Investors were told HOPE-3 results supported approval, but the FDA later challenged the statistical analysis behind those claims.

Capricor shares fell sharply after FDA briefing documents were released on July 27, 2026. The stock dropped again after a non-binding FDA advisory committee vote raised further doubts about Deramiocel’s efficacy.

Company Profile

Capricor Therapeutics, Inc. is a biotechnology company focused on developing cell and exosome-based therapeutics for the treatment of Duchenne muscular dystrophy, a rare genetic disorder marked by progressive muscle degeneration and premature death. Its lead product candidate is Deramiocel, a cell therapy intended to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.

Class Period

December 17, 2025 – July 26, 2026

Investors who purchased or acquired Capricor Therapeutics, Inc. (CAPR) securities during the Class Period may be eligible to seek recovery under federal securities laws.

Allegations

The complaint alleges that Capricor and its senior executives publicly presented Deramiocel as moving toward potential approval after the company submitted a Biologics License Application to the FDA in late 2024. The FDA issued a Complete Response Letter in July 2025, stating that the application did not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data were needed.

On December 17, 2025, Capricor participated in a webinar with Parent Project Muscular Dystrophy to discuss positive topline results from the Phase 3 HOPE-3 trial. During the webinar, Chief Executive Officer Linda Marban stated that the primary efficacy endpoint was statistically significant, that key secondary endpoints also showed statistical significance, and that the data should answer all questions raised in the FDA's Complete Response Letter.

Capricor repeated similar regulatory and clinical messages in later public statements. In a January 20, 2026 press release, the company said the FDA had requested the full HOPE-3 clinical study report and supporting data, but had not requested additional clinical studies or new patient data. On March 10, 2026, Capricor announced that the FDA had resumed review of the Deramiocel BLA, assigned an August 22, 2026 PDUFA target action date, and had not identified potential review issues in its response to the company.

The complaint alleges these statements were materially false and misleading because defendants failed to disclose that Capricor had adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel clinical data. Plaintiffs further allege the FDA had not agreed to those changes before the BLA resubmission, creating a significant risk that the agency could view the results as insufficient evidence of effectiveness and that Deramiocel's regulatory approval was at substantial risk.

The Truth Emerges

Before the market opened on July 27, 2026, the FDA released briefing documents ahead of the July 29 advisory committee meeting for the Deramiocel BLA. According to the complaint, the briefing documents stated that Capricor made changes to the pre-specified statistical analysis plan and that the final version was not submitted to the FDA for review before the BLA submission, was not discussed, and was not agreed upon.

The FDA briefing documents also stated that the HOPE-3 study did not meet its pre-specified primary and secondary efficacy endpoints. The agency said the final statistical analysis plan was dated November 24, 2025, one day before the data was unblinded, and that analyses based on post-study SAP versions were post-hoc and exploratory. The FDA further stated that the benefit-risk assessment for Deramiocel appeared unfavorable in the absence of evidence of effectiveness.

Capricor issued an update later that morning, stating it had engaged fully and transparently with the FDA and disputing reliance on what it called an unsigned incomplete internal draft. On July 30, 2026, Medscape reported that the advisory committee relied on SAP version 1.1 as the prespecified plan and issued a non-binding 9-3 vote concluding that the available evidence did not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy.

Market Reaction

Following the FDA briefing documents and related investor reaction on July 27, 2026, Capricor's stock fell $12.70, or 64%, to close at $7.00 per share on unusually heavy trading volume. The complaint also cites a Cantor Fitzgerald investor note stating that the FDA briefing documents "paint an ugly picture" and raised concerns about data integrity.

After Medscape reported the advisory committee's non-binding 9-3 vote, Capricor's stock fell another $2.38, or 36%, to close at $4.19 per share on July 30, 2026, again on unusually heavy trading volume. The complaint alleges these declines reflected the market's reaction to information that contradicted defendants' prior positive statements about Deramiocel's clinical evidence and regulatory prospects.

Next Steps

●       Lead Plaintiff Deadline: September 28, 2026

●       After the lead plaintiff deadline, the Court will consider any lead plaintiff motions.

●       Defendants may file a motion to dismiss.

●       If the case proceeds, the Court may later consider class certification.

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. Prior results do not guarantee similar outcomes.