Capricor faces shareholder lawsuit over HOPE-3 trial disclosures
A shareholder alert says investors filed a securities class action against Capricor Therapeutics over disclosures tied to its HOPE-3 trial and later FDA briefing materials.
A shareholder alert says investors filed a securities class action against Capricor Therapeutics over disclosures tied to its HOPE-3 trial and later FDA briefing materials.
What happened
A PR Newswire investor alert dated Aug. 26, 2026, says investors filed a securities class action against Capricor Therapeutics Inc. The release, issued by Levi & Korsinsky, says the case involves purchasers of Capricor securities between Dec. 17, 2025, and July 26, 2026.
The alert says the lawsuit centers on Capricor’s Phase 3 HOPE-3 trial in Duchenne muscular dystrophy. According to the release, the complaint alleges the company changed the pre-specified statistical analysis plan for the study without agreement from the U.S. Food and Drug Administration.
Why it matters
The release says the dispute concerns how the company presented trial results to investors and regulators. It says Capricor told the market HOPE-3 showed statistically significant results, while FDA briefing documents released July 27, 2026, described the study differently.
According to the release, FDA materials said the trial “did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference,” and that the benefit-risk assessment “appears unfavorable in the absence of evidence of effectiveness.” The allegations have not been adjudicated.
Context and background
The release describes HOPE-3 as a randomized, double-blind, placebo-controlled 12-month study in 106 patients with Duchenne muscular dystrophy. It says that after the blinded portion ended, at least two additional versions of the statistical analysis plan were created.
Levi & Korsinsky says those later versions changed primary and key secondary endpoint definitions, analytical methods, and the data imputation strategy for certain intercurrent events. The alert also says the final version of the plan was not submitted to the FDA before the biologics license application was filed and was never agreed upon.
The release says Capricor had told the market HOPE-3 produced statistically significant results, including a p-value of 0.03 on the primary endpoint and 0.04 on the key secondary cardiac endpoint. It also says CAPR shares lost about 78.7% of their value across two trading sessions in late July 2026.
What the release says
The alert says the case was filed in the U.S. District Court for the Southern District of California under the Private Securities Litigation Reform Act of 1995. It says lead plaintiff motions must be filed by Sept. 28, 2026.
The release names Joseph E. Levi, Esq. as a contact at Levi & Korsinsky and says the firm is notifying investors in Capricor Therapeutics, which trades on Nasdaq under the ticker CAPR.
What happens next
According to the release, investors who bought Capricor securities during the stated class period may seek to join the case before the Sept. 28 deadline. The lawsuit’s claims remain allegations in the source material.
Sources
Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.
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