Capricor Therapeutics Investors Have Until September 28 for Class Action Participation

Significant Deadline for Capricor Therapeutics Investors

Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) facing noteworthy financial losses have a crucial opportunity to lead a shareholder class action lawsuit before the approaching September 28, 2026 deadline. This opportunity arises amid ongoing scrutiny following recent developments regarding the company’s lead investigational product, deramiocel, for treating Duchenne muscular dystrophy (DMD).

Context of the Situation

On September 14, 2026, the well-known plaintiffs' rights law firm Hagens Berman Sobol Shapiro LLP issued a notification indicating that significant losses incurred by investors provide grounds for potential legal action against Capricor. This notice correlates with a recent decision by the U.S. Food and Drug Administration (FDA), which extended the review timeline for Capricor's Biologics License Application (BLA) for deramiocel, shifting the target date from August 22, 2026, to November 22, 2026. This extension has raised several concerns regarding the company's regulatory practices and the nature of communications provided to stakeholders.

Allegations and Legal Basis

The ongoing lawsuit is predicated on allegations that Capricor and its executive team made materially false and misleading statements concerning clinical trial data and their regulatory processes regarding Deramiocel. Specifically, it is claimed that the company neglected to disclose modifications made to the pre-specified statistical analysis plan (SAP) without prior FDA agreement prior to resubmitting the BLA.

In December 2025, Capricor had announced positive results from the pivotal Phase 3 HOPE-3 study of Deramiocel, asserting the therapy's ability to deliver meaningful improvements in the treatment of DMD. Following these claims, there was a notable surge in the company’s share price, which increased by 370%, compelling the company to offer approximately six million shares publicly at $25 each.

However, the reality shifted drastically when the FDA released briefing documents ahead of an Advisory Committee meeting in July 2026. These documents outlined the failure of the HOPE-3 study to meet its pre-specified primary and secondary endpoints, asserting no statistically significant difference between Deramiocel and a placebo at 12 months. Following this revelation, Capricor’s stock experienced a staggering 64% decline in just one day, closing at $7.00. The Advisory Committee subsequently voted against the drug's efficacy, exacerbating investor losses.

What Affected Investors Should Do

Investors who purchased or otherwise acquired Capricor securities between December 17, 2025, and July 26, 2026, and experienced significant financial detriment are urged to act swiftly. They have until September 28, 2026, to express their interest in being appointed as lead plaintiff. However, it is crucial to note that investors do not have to apply for lead plaintiff status to share in any potential recovery outcomes resulting from this legal action.

For those seeking more information on their legal options, Hagens Berman invites them to submit their contact details through their website, call Reed Kathrein at 844-916-0895, or email [email protected]. Furthermore, individuals privy to non-public information regarding Capricor are encouraged to consider their options, including participation in the SEC Whistleblower program, which may provide substantial rewards for original information leading to successful recoveries.

About Hagens Berman

Hagens Berman is recognized globally for holding corporations accountable and specializing in complex litigation aimed at protecting the rights of shareholders, consumers, and workers. With over $2.9 billion secured for clients harmed by corporate misconduct, they maintain a commitment to justice. For ongoing updates regarding the Capricor case and others, follow Hagens Berman on social media at @ClassActionLaw.