Capricor Therapeutics, Inc. CAPR Securities Class Action Lawsuit

• 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
• Lawsuit Type: Securities Class Action

Introduction

A securities class action lawsuit was filed on July 30, 2026 in the United States District Court for the Southern District of California against Capricor Therapeutics, Inc., Chief Executive Officer Linda Marban, and Chief Financial Officer Anthony J. Bergmann. The case seeks to represent investors who purchased or otherwise acquired Capricor securities between December 17, 2025 and July 26, 2026, inclusive.

Capricor Therapeutics, Inc. told the market a story of regulatory momentum. Its lead therapy, Deramiocel, had already drawn a Complete Response Letter from the FDA in July 2025, but the company later presented HOPE-3 data as the answer. Investors were told the FDA had resumed review, that the submission was complete, that no additional clinical studies or new patient data had been requested, and that the company was preparing for a potential commercial launch.

According to the complaint, the hidden problem sat inside the statistics. Capricor allegedly changed the pre-specified statistical analysis plan used to analyze Deramiocel clinical data, and the FDA allegedly had not agreed to those changes before the company resubmitted the BLA. When FDA briefing documents surfaced before the advisory committee meeting, they raised questions about the prespecified status, reliability, and usefulness of the analyses. CAPR fell sharply, then fell again after the advisory committee issued a non-binding 9–3 vote that the available evidence did not support Deramiocel’s efficacy for DMD-associated cardiomyopathy.

Backdrop and Business Context

Capricor traces its scientific roots to cardiosphere-derived cell technology associated with Dr. Eduardo Marban and was founded as Capricor, Inc. in 2005. The company later became Capricor Therapeutics, Inc. through a 2013 merger with Nile Therapeutics, and its shares began trading on the Nasdaq Capital Market under the ticker CAPR in 2015. The company's strategic thread has narrowed over time: from broad regenerative cardiology toward Duchenne muscular dystrophy and exosome-based therapeutics. A more recent public financing, announced in December 2025, involved 6,000,000 shares priced at $25.00 per share for expected gross proceeds of $150 million.

Capricor is a clinical-stage biotechnology company headquartered in San Diego, California. Its lead program is Deramiocel, also known as CAP-1002, an allogeneic cardiac-derived cell therapy being developed for Duchenne muscular dystrophy, a rare genetic disease marked by progressive muscle degeneration. Capricor also develops its StealthX exosome platform, which is designed for therapeutic delivery applications involving nucleic acids, proteins, and small molecules. The company remains pre-commercial. Capricor’s 2025 Form 10-K reported no revenue for fiscal 2025, compared with approximately $22.3 million in 2024, primarily from its U.S. distribution agreement with Nippon Shinyaku.

The company's business model depends heavily on regulatory progress, clinical trial interpretation, partnership economics, equity financing, and future commercialization. In the broader DMD market, Capricor faces competition from approved therapies and product candidates in development, although Deramiocel occupies a distinct cell-therapy niche. That regulatory dependency is central to the lawsuit: according to the complaint, investors were not told that changes to Deramiocel's statistical analysis plan created a significant risk that FDA would view the evidence as insufficient.

Promises Made vs. Reality

The alleged misstatements began with Capricor's December 17, 2025 webinar with Parent Project Muscular Dystrophy. During that presentation, CEO Linda Marban described topline Phase 3 HOPE-3 results as favorable across skeletal and cardiac measures. She told the audience that the Performance of the Upper Limb 2.0 endpoint was statistically significant and that cardiac function also showed improvement and statistical significance in patients treated with Deramiocel compared with placebo.

Marban also emphasized the statistical strength of the results. She stated that multiple measures were "type 1 error controlled," explaining that such controls impose tight mathematical limits on whether observed results could be due to chance rather than treatment effect. The message was direct: taken together, Capricor would present the data to the FDA, and the company believed the data "should answer all the questions" raised in the FDA's Complete Response Letter.

Capricor reinforced that message on January 20, 2026. In a regulatory update, the company stated that the FDA had formally requested the full HOPE-3 clinical study report and supporting data, and that the FDA did not request any additional clinical studies or new patient data. Marban characterized the request as an expected next step and said the HOPE-3 results showed "statistically significant and clinically meaningful improvements" in both skeletal muscle and cardiac function.

By March 2026, the company's public narrative shifted from response to momentum. On March 10, Capricor announced that the FDA had lifted the previously issued Complete Response Letter and resumed review of the Deramiocel BLA, with a PDUFA target action date of August 22, 2026. The release stated that the FDA had not identified any potential review issues in its response to the company. Two days later, Capricor told investors it entered 2026 with "important regulatory and clinical momentum" and highlighted that the HOPE-3 trial met its primary endpoint and key secondary cardiac endpoint, each achieving statistical significance.

The same optimism appeared in formal SEC reporting. In its March 17, 2026 Form 10-K, Capricor stated that after a Type A meeting with the FDA, it had aligned with the agency on a regulatory path forward to address the CRL, including submission of additional HOPE-3 data. Then, in a May 12, 2026 corporate update, the company said the BLA remained under FDA review, that the agency had accepted the Class 2 resubmission as complete, and that Capricor expected labeling discussions to commence soon.

The reality alleged by the lawsuit was different. The FDA's July 27, 2026 briefing documents stated that Capricor made changes to the pre-specified statistical analysis plan, that the final version was not submitted for FDA review before BLA submission, and that it was not discussed or agreed upon. The FDA said it considered analyses based on the post-study SAP versions "post-hoc and exploratory" and that the benefit-risk assessment appeared unfavorable absent evidence of effectiveness. As alleged in the complaint, defendants' positive statements allegedly omitted that Capricor had adopted SAP changes, that FDA had not agreed to them before resubmission, and that these facts created substantial regulatory risk for Deramiocel.

Timeline of Alleged Misconduct and Disclosures

Class Period: December 17, 2025 – July 26, 2026, inclusive.

• Late 2024: Capricor submitted its Biologics License Application to the FDA for Deramiocel as a cell therapy for Duchenne muscular dystrophy.
• July 2025: The FDA issued a Complete Response Letter stating that the BLA did not meet the statutory requirement for substantial evidence of effectiveness and required additional clinical data.
• December 17, 2025: Class period opened. Capricor participated in a Parent Project Muscular Dystrophy webinar to discuss positive topline Phase 3 HOPE-3 results and regulatory discussions. Linda Marban described statistically significant results and stated that the data should answer the FDA's CRL questions.
• January 20, 2026: Capricor issued a regulatory update stating that the FDA had requested the full HOPE-3 clinical study report and supporting data, and had not requested additional clinical studies or new patient data.
• March 10, 2026: Capricor announced that the FDA had lifted the previously issued Complete Response Letter and resumed review of the Deramiocel BLA. The company announced a PDUFA target action date of August 22, 2026 and stated that the FDA had not identified potential review issues in its response.
• March 12, 2026: Capricor announced fourth quarter and full-year 2025 financial results and provided a corporate update, describing regulatory and clinical momentum and potential approval of Deramiocel.
• March 17, 2026: Capricor filed its Form 10-K for the year ended December 31, 2025. The filing stated that Capricor had aligned with the FDA on a regulatory path forward after an August 2025 Type A meeting and that the FDA accepted the response as complete.
• April 21, 2026: Capricor's share price closed at a class period high of $35.34 per share, according to the complaint.
• May 12, 2026: Capricor announced first quarter 2026 financial results and said the Deramiocel BLA was under FDA review, that the Class 2 resubmission had been accepted as complete, and that labeling discussions were expected to commence soon.
• July 27, 2026: Alleged corrective disclosure. Before the market opened, the FDA released briefing documents ahead of the Deramiocel advisory committee meeting. The documents stated that Capricor changed the pre-specified SAP, that the final version was not submitted to FDA before BLA submission, and that FDA considered analyses based on post-study SAP versions post-hoc and exploratory.
• July 27, 2026: Capricor issued an update ahead of the advisory committee meeting, stating that it had engaged fully and transparently with FDA and disputing the FDA's use of SAP version 1.1.
• July 27, 2026: Cantor Fitzgerald published an investor note stating that the FDA briefing documents "paint an ugly picture" and raised concerns about data integrity. CAPR fell $12.70, or 64%, to close at $7.00 per share.
• July 29, 2026: The FDA advisory committee met to discuss the Deramiocel BLA.
• July 30, 2026: Alleged corrective disclosure. Medscape reported that the panel relied on SAP version 1.1 as the prespecified plan and in a non-binding 9–3 vote, the panel concluded that the available evidence did not support Deramiocel's efficacy for DMD-associated cardiomyopathy. CAPR fell $2.38, or 36%, to close at $4.19 per share.
• July 30, 2026: The complaint was filed in the United States District Court for the Southern District of California.

Investor Harm and Market Reaction

The first major market reaction occurred on July 27, 2026, after the FDA released briefing documents ahead of the advisory committee meeting. The documents stated that Capricor had changed the pre-specified statistical analysis plan, that the final version was not submitted for FDA review before the BLA submission, and that FDA viewed the post-study analyses as post-hoc and exploratory. On that news, CAPR fell $12.70, or 64%, to close at $7.00 per share on unusually heavy trading volume.

The second decline followed the advisory committee meeting. On July 30, 2026, Medscape reported that the panel relied on SAP version 1.1 as the prespecified plan and in a non-binding 9–3 vote, the panel concluded that the available evidence did not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy. CAPR fell another $2.38, or 36%, to close at $4.19 per share, also on unusually heavy trading volume.

The complaint places those declines against a much higher class period market price. It alleges that Capricor's share price closed at a class period high of $35.34 on April 21, 2026, before the alleged truth emerged. Investors who purchased Capricor securities during the class period allegedly bought at prices inflated by statements about Deramiocel's clinical evidence, the regulatory path, and the likelihood that the BLA review would continue toward approval.

Litigation & Procedural Posture

The complaint asserts claims under Section 10(b) of the Exchange Act and Rule 10b-5 against all defendants, and Section 20(a) control-person claims against the individual defendants. Capricor Therapeutics, Inc. is named as the issuer, while Linda Marban and Anthony J. Bergmann are named based on their roles as senior executives.

Defendants: Capricor Therapeutics, Inc., CEO Linda Marban, and CFO Anthony J. Bergmann.

Scienter allegations center on the individual defendants' senior roles, access to non-public information, and alleged control over Capricor's SEC filings, press releases, and investor communications. The complaint alleges that the individual defendants knew, or recklessly disregarded, that adverse facts concerning the SAP changes and FDA agreement had not been disclosed.

Procedurally, the case is at the initial complaint stage. The proposed class consists of all persons and entities that purchased or otherwise acquired Capricor securities between December 17, 2025 and July 26, 2026, inclusive, and were damaged thereby. The complaint seeks class certification, damages, costs, and a jury trial. Lead plaintiff submissions are due September 28, 2026.

How to Check Eligibility in the Capricor Therapeutics, Inc. (CAPR) Class Action

• Confirm you purchased CAPR shares during the December 17, 2025 to July 26, 2026 class period
• Review the allegations and eligibility requirements in the pending securities class action
• Gather trade confirmations and brokerage records documenting purchases or losses
• Consult counsel regarding [lead deadlines, eligibility, and recovery rights

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