Capricor Therapeutics (NASDAQ: CAPR) Securities Class Action: Expanded Class Period, Deramiocel FDA Issues, and Investor Rights

The new lawsuit concerns Capricor's investigational Duchenne muscular dystrophy therapy Deramiocel and the pivotal Phase 3 HOPE-3 trial.

Plaintiff alleges that Capricor repeatedly described HOPE-3 as providing strong, statistically significant evidence of efficacy while failing to adequately disclose a disagreement with the U.S. Food and Drug Administration (FDA) concerning changes to the trial's statistical-analysis methodology.

Specifically, plaintiff alleges investors were not adequately informed that:

• Capricor changed the pre-specified statistical analysis plan used to analyze HOPE-3;
• FDA had not agreed to those changes before the BLA resubmission;
• FDA could therefore view the resulting analyses as post-hoc rather than pre-specified;
• this created a substantial risk that FDA would conclude HOPE-3 did not provide substantial evidence of effectiveness; and
• Deramiocel's regulatory prospects were therefore more uncertain than investors allegedly understood.

These are allegations. No court has determined that Capricor committed securities fraud, and they have not been proven.

Investors researching this case may see two different start dates. An earlier 2026 complaint, Nkamga v. Capricor Therapeutics, used a proposed class period beginning December 17, 2025. The later Novick complaint — filed September 28, 2026 — alleges an expanded class period beginning December 3, 2025, the date Capricor announced its HOPE-3 topline results.

Older search results may still show December 17. Investors who purchased CAPR between December 3 and December 16, 2025 should therefore be aware of the expanded allegations in Novick.

The Novick docket identifies Nkamga (No. 3:26-cv-04385) as a related case. The two 2026 complaints concern substantially overlapping allegations rather than competing fraud theories.

Deramiocel is Capricor's investigational allogeneic cell therapy for Duchenne muscular dystrophy (DMD).

DMD is a rare genetic disease that causes progressive loss of skeletal- and cardiac-muscle function.

Capricor has studied Deramiocel through its HOPE clinical-development program, including HOPE-2, its open-label extension, and the pivotal Phase 3 HOPE-3 trial. The company's Biologics License Application (BLA) seeks FDA approval for Deramiocel.

A Statistical Analysis Plan, or SAP, specifies in advance how a clinical trial's data will be analyzed.

Pre-specification matters because deciding on endpoints, statistical methods, data-handling rules, and analysis populations before the results are known helps guard against the concern that an analysis was designed around the observed data. FDA's own briefing materials emphasize that statistical methodology should ordinarily be finalized before a study is completed and unblinded.

FDA's July 2026 briefing materials questioned changes Capricor made to the HOPE-3 analysis plan after the study's double-blind portion had been completed. Capricor disputes important aspects of FDA staff's characterization, as described below.

The Novick class period begins December 3, 2025. On that date, Capricor announced positive HOPE-3 topline results and described them as strong evidence that Deramiocel could meaningfully improve skeletal- and cardiac-related outcomes in DMD. CEO Linda Marbán stated that the company believed the pivotal study could address issues raised in FDA's earlier Complete Response Letter.

Shortly afterward, Capricor raised substantial capital. On December 5, 2025 it priced an underwritten offering of 6,000,000 common shares at $25.00 per share, for expected gross proceeds of approximately $150 million; with the underwriters' option later fully exercised, gross proceeds rose to approximately $172.5 million.

Plaintiff alleges that investors had not been informed about the statistical-analysis-plan issues later highlighted by FDA. This is the plaintiff's allegation and has not been proven.

Yes. This was not Capricor's first FDA setback. In July 2025, FDA issued a Complete Response Letter (CRL) stating that the BLA could not be approved in its then-current form; Capricor described the CRL as citing a lack of substantial evidence of effectiveness and the need for additional clinical data.

Capricor then relied on the Phase 3 HOPE-3 trial in its effort to address FDA's earlier concerns. That 2025 CRL also gave rise to an earlier, separate securities lawsuit, discussed below.

FDA's review continued into 2026. On January 20, 2026, Capricor announced that FDA had requested the complete HOPE-3 clinical study report and supporting data, and stated that FDA had not requested another clinical study.

On March 10, 2026, Capricor announced that FDA had resumed its review of the BLA and set a PDUFA target action date of August 22, 2026. In May, the company described the BLA as actively under review and highlighted additional HOPE-3 presentations, commercial-launch preparation, and a completed FDA manufacturing inspection.

Plaintiff alleges that, throughout this period, investors still were not adequately informed about the unresolved disagreement over the statistical-analysis methodology.

On July 27, 2026, FDA released briefing materials ahead of its Deramiocel Advisory Committee meeting. This is the primary alleged corrective disclosure in the case.

The briefing materials stated that, under the earlier pre-specified analyses, HOPE-3 had not met its primary and secondary endpoints, and described multiple post-study changes to the SAP. According to the materials, additional SAP versions were generated after the double-blind portion was completed, endpoint definitions and analytical and data-imputation methods were modified, and the final SAP version (dated November 24, 2025) was not submitted to FDA for review before the BLA submission and had not been agreed to by FDA. FDA staff characterized certain later analyses as post-hoc and exploratory.

FDA's own document notes that Advisory Committee background materials may contain reviewer assessments and do not necessarily represent FDA's final regulatory position.

According to the complaint, CAPR fell approximately $12.70 per share, or about 64%, to close at approximately $7.00 on July 27.

Capricor immediately disputed important aspects of FDA staff's analysis. The company stated that FDA's criticism relied on an early, incomplete internal draft of the SAP (version 1.1) that it said became obsolete after cohort changes, and maintained that its results were governed by a final SAP (version 3.0) finalized before unblinding. Capricor also stated that it had engaged transparently with FDA.

In short, plaintiff alleges that changes to the SAP were inadequately disclosed; FDA staff questioned those changes; and Capricor disputes FDA's characterization and maintains that its final analysis plan was appropriate and completed before data unblinding. The litigation will likely address what management knew, what investors were told, and whether additional disclosure was required before July 27.

On July 29, 2026, FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 3 in favor and 9 against (with no abstentions) on whether the available evidence provided substantial evidence of Deramiocel's effectiveness for DMD-associated cardiomyopathy.

The vote was advisory and non-binding; FDA remains responsible for the final decision. Capricor has emphasized that the committee's voting question focused on cardiomyopathy and that the committee was not asked to vote on HOPE-3's primary endpoint involving upper-limb function, where the company says the evidence and the committee's separate discussion were more favorable.

According to the complaint, CAPR fell another approximately $2.38 per share, or about 36%, to close at approximately $4.19 on July 30.

Not as of the current date. FDA has not rejected Deramiocel, and the BLA remains under review.

After the Advisory Committee meeting, Capricor continued working with FDA. On August 24, 2026 it submitted additional 24-month HOPE-3 open-label-extension data and robustness analyses and requested consideration of a refined proposed indication focused on upper-limb function (HOPE-3's primary endpoint). FDA accepted the submission as a major amendment and extended the PDUFA target date from August 22 to November 22, 2026.

The final FDA decision remains pending, and its outcome is uncertain. These developments occurred after the July 26, 2026 end of the alleged class period and are provided as context, not as part of the complaint's allegations.

Section 10(b) and Rule 10b-5

The complaint asserts federal securities-fraud claims under Section 10(b) and Rule 10b-5 against Capricor, Marbán, and Bergmann.

Section 20(a)

The complaint also asserts controlling-person claims against the individual defendants.

The Novick complaint alleges a class period of December 3, 2025 through July 26, 2026, inclusive.

Investors should preserve complete brokerage statements and trade confirmations showing all CAPR purchases and sales.

The previously published PSLRA lead plaintiff deadline was September 28, 2026, and that deadline has passed. Because the Novick docket identifies the earlier Nkamga action as a related case, the filing of Novick on September 28 should not be assumed to create a new 60-day deadline unless a later court order or a new authoritative PSLRA notice establishes one.

Does That Mean I Cannot Be Part of the Class?

Not necessarily. A lead-plaintiff deadline concerns investors seeking appointment to actively represent the proposed class. That is different from whether an investor may ultimately qualify as a passive class member if a class is later certified or a settlement is reached.

Lead Plaintiff Deadline ≠ Settlement Claim Deadline

These are different dates. Investors should continue preserving complete CAPR transaction records.

No. An earlier 2025 securities action, Leong v. Capricor Therapeutics, Inc. (filed July 17, 2025), concerned statements made before FDA issued its July 2025 Complete Response Letter and focused on the earlier evidence for Deramiocel.

The current 2026 litigation concerns the subsequent HOPE-3 trial, the BLA resubmission, the alleged undisclosed changes to the statistical-analysis plan, and FDA's July 2026 briefing materials.

Potentially. The Novick class period begins December 3, 2025, and Capricor priced a large underwritten stock offering at $25.00 per share several days later. Investors who purchased CAPR through that offering should preserve their complete transaction records.

The current complaint asserts Exchange Act claims and does not presently assert a separate Securities Act (for example, Section 11) offering claim.

Yes. Capricor's SEC filings disclose shareholder derivative actions filed in 2025 (two of which were consolidated in December 2025), a Delaware Section 220 books-and-records demand and a separate shareholder litigation demand, and a further derivative action filed in August 2026 following the new FDA developments.

Julie & Holleman's investigation therefore does not concern whether any Capricor derivative litigation exists at all. Instead, it concerns whether the new HOPE-3, FDA, and statistical-analysis allegations may create additional or overlapping derivative and corporate-governance rights for current shareholders — including rights not fully encompassed by the previously filed derivative litigation.

Potentially. Capricor is incorporated in Delaware. Julie & Holleman LLP is interested in speaking with shareholders who owned CAPR at the time of potentially actionable conduct and have continued to hold their shares. Different alleged acts occurred at different times — for example, a shareholder who purchased in January 2026 might potentially have standing concerning later alleged conduct that occurred while that shareholder owned CAPR.

Potential areas of investigation include:

• clinical-trial and SAP oversight;
• FDA communications and how they were reported to the board;
• disclosure controls over statements describing HOPE-3;
• BLA and regulatory-risk oversight;
• the December 2025 capital raise; and
• Rule 10b5-1 trading plans adopted by company officers.

Because prior derivative actions and demands already exist, standing, overlap, coordination, and demand issues must be analyzed before any new claim is pursued. No determination has been made that additional derivative claims are viable or non-duplicative of existing litigation.

Julie & Holleman LLP is investigating allegations involving Capricor Therapeutics, CAPR, Deramiocel, Duchenne muscular dystrophy, HOPE-3, statistical-analysis-plan changes, FDA communications, the BLA resubmission, FDA Advisory Committee materials, capital raising, disclosure controls, and corporate governance. We are interested in hearing from:

Investors With Securities Losses

Investors who purchased or otherwise acquired Capricor securities from December 3, 2025 through July 26, 2026 and suffered losses. Although the previously published lead-plaintiff deadline has passed, qualifying investors may still wish to monitor the litigation and preserve their transaction records.

Current CAPR Shareholders

Shareholders who owned CAPR at the time of potentially actionable conduct and continue to hold their shares, concerning possible additional or overlapping derivative and corporate-governance rights.