#United States #San Francisco #Securities Class Action #deramiocel #Capricor Therapeutics

Investors Urged to Act: Capricor Therapeutics Class Action Lawsuit

Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) have a crucial opportunity to participate in a shareholder class action lawsuit aiming to address substantial financial losses following recent regulatory developments. The deadline to act is September 28, 2026, and this may be a pivotal moment for those impacted.

Following a turbulent period, including a significant extension of the FDA’s review of Capricor’s Biologics License Application (BLA) concerning their cell therapy, deramiocel, the legal challenges surrounding the company have intensified. As many investors are now aware, the FDA recently prolonged its review period for the application from August 22 to November 22, 2026. This extension illuminates ongoing scrutiny over Capricor’s disclosures and clinical trial outcomes.

Background on the Lawsuit

On August 24, Capricor announced that the FDA had asked for additional information, following a July Advisory Committee meeting that raised considerable concerns. The meeting involved discussions around the efficacy of deramiocel, which is in development for treating Duchenne muscular dystrophy (DMD). The amended submission from Capricor entails information from the 24-month open-label extension data of its Phase 3 HOPE-3 study – deemed essential by the FDA for evaluating their approach.

This transparency comes at a time when Capricor has faced allegations of making misleading statements related to the clinical trial data and changes in their statistical analysis plan. According to the lawsuit, Capricor and its executives did not disclose critical changes made to the pre-specified plan before resubmitting the BLA.

Notable Developments

The timeline for this situation can be traced back to December 3, 2025, when Capricor announced positive results from the HOPE-3 trial, contributing to a staggering 370% jump in their stock price. Following this announcement, they also initiated a public stock offering, leading many investors to believe in the substantial potential of its leading candidate, deramiocel.

However, this optimism quickly reversed on July 27, 2026, when the FDA released briefing documents unveiling unapproved modifications to the trial’s analysis methods, leading to a dramatic stock decrease of 64%, closing at $7.00 per share. The fallout from the Advisory Committee meeting, which voted against the drug's efficacy, has left many shareholders grappling with significant losses.

What Investors Can Do

Investors who purchased or acquired Capricor securities between December 17, 2025, and July 26, 2026, and have experienced notable financial setbacks are urged to consider joining the class action by reaching out to Hagens Berman, the firm handling this case. Even those not seeking lead plaintiff status can still participate in any potential recovery resulting from a favorable outcome.

For further information regarding your legal standing or to initiate claims, potential class members can visit Hagens Berman's website or reach out directly at 844-916-0895. The communication avenues, which also welcome whistleblowers or anyone with non-public information, may prove vital in strengthening the investigation.

About Hagens Berman

Hagens Berman is known for its commitment to corporate accountability, representing a wide array of clients impacted by corporate negligence. With over $2.9 billion secured in damages, this firm is at the forefront of advocating for shareholders in similar situations. Updates and pertinent information can be followed via their social media and website.

With the imminent deadline looming, investors must act swiftly. The class action lawsuit represents not just a chance to recoup losses, but also a platform for holding corporate leadership accountable for their obligations to shareholders and the integrity of the medical product development process.