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LOS ANGELES, Sept. 05, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR) investors of a class action representing investors that bought securities between October 9, 2024 and July 10, 2025, inclusive (the "Class Period"). Capricor investors have until September 15, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
CASE ALLEGATIONS: Capricor is a clinical-stage biotechnology company developing transformative cell- and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”) and other diseases.
The Capricor class action lawsuit alleges that throughout the Class Period, defendants made false or misleading statements and/or failed to disclose adverse facts concerning four-year safety and efficacy data from its Phase 2 HOPE-2 trial, giving the false impression that Capricor could obtain first approval for DMD cardiomyopathy.
The complaint further alleges that on May 5, 2025, Capricor announced it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (“FDA”) for deramiocel, reporting no significant deficiencies and confirming that the application remained on track for a Prescription Drug User Fee Act action date of August 31, 2025. The FDA also confirmed its intent to hold an advisory committee meeting. According to the complaint, on this news, Capricor’s stock fell more than 29%.
The Capricor class action lawsuit further alleges that on June 20, 2025, Stat News reported that Vinjay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, canceled the advisory committee meeting due to skepticism regarding deramiocel’s efficacy and safety. On this news, Capricor’s stock fell more than 30%, according to the complaint.
Finally, on July 11, 2025, the complaint alleges that Capricor announced it had received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel, citing insufficient evidence of effectiveness and the need for additional clinical data. On this news, Capricor’s stock fell nearly 33%, according to the complaint.
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The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.
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