CAPR INVESTOR ALERT: Kirby McInerney LLP Announces Investigation Into Potential Securities Fraud
NEW YORK, July 28, 2026 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR). The investigation concerns whether the Company and/or members of its senior management may have violated federal securities laws or engaged in other unlawful business practices.
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What Happened?
On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting with Capricor regarding the Company’s lead product candidate, deramiocel, a cell therapy for a heart condition related to Duchenne muscular dystrophy. Among other things, the briefing documents revealed that agency staff concluded Capricor’s data did not provide “substantial evidence of effectiveness,” noting that approval generally requires at least two adequate and well-controlled studies while deramiocel’s application rested on a single pivotal trial. In a story covering the news, Stat News wrote that “[a]fter the study was completed, the FDA said, Capricor made a litany of changes to its statistical analysis plan, a crucial document outlining how a study will be measured. Revising that plan after a study is done raises concerns that a company may be looking to generate a positive outcome when there wasn’t one based on its original design.”
Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. The Company had also characterized its Biologics License Application as on track ahead of an August 2026 PDUFA date and pointed to positive long-term clinical data.
On this news, Capricor’s stock price fell $12.70 per share, or approximately 64.5%, to close at $7.00 per share on July 27, 2026.
What Should I Do?
At this stage, no lawsuit has been filed. The investigation is ongoing to determine whether claims may be brought under federal securities laws.
If you purchased or otherwise acquired Capricor securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.
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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Contacts
Kirby McInerney LLP
Lauren Molinaro, Esq.
212-699-1171
https://www.kmllp.com
https://securitiesleadplaintiff.com/
investigations@kmllp.com
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