Capricor Therapeutics, Inc. CAPR Investors With Significant Losses Encouraged to Contact Kirby McInerney LLP About Securities Class Action
NEW YORK CITY, NY / ACCESS Newswire / September 17, 2026 / ( ACCESS NEWSWIRE)-The law firm of Kirby McInerney LLP reminds Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ:CAPR) investors who acquired Capricor securities between December 17, 2025 and July 26, 2026, inclusive ("the Class Period") of the September 28, 2026 deadline to seek lead plaintiff appointment in the pending class action lawsuit.
Investors are encouraged to contact Lauren Molinaro of Kirby McInerney LLP by email at [email protected], or fill out the contact form below to discuss your rights or interests in the securities fraud class action lawsuit at no cost.
[ CONTACT THE FIRM IF YOU SUFFERED A LOSS]
What Is The Lawsuit About?
The lawsuit alleges Capricor made materially false and/or misleading statements and failed to disclose to investors that: (i) the Company adopted changes to the pre-specific statistical analysis plan used to analyze clinical data for its lead product candidate, Deramiocel; (ii) the FDA had not agreed to those changes before the Company resubmitted the Deramiocel Biologics License Application ("BLA"); (iii) as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of the effectiveness of Deramiocel; and (iv) as a result, there was substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.
On July 27, 2026, the FDA released briefing documents prior to its advisory committee meeting for the Deramiocel BLA, which revealed that Capricor made changes to the pre-specified statistical analysis plan and that the final version "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon." The FDA disagreed with the changes and stated, "the benefit-risk assessment for Deramiocel appears unfavorable in the absence of evidence of effectiveness." On this news, Capricor's stock price fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026.
On July 30, 2026, Medscape reported that the FDA advisory committee, which met on July 29, 2026, voted 9-3 to conclude "that the available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy." On this news, Capricor's stock price fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026.
[ CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]
What Should I Do?
Courts do not consider applications filed after the lead plaintiff deadline. The lead plaintiff oversees the litigation on behalf of the class and may influence key decisions, including litigation strategy and settlement. Courts regularly appoint individual investors as lead plaintiffs, not only institutions. Learn more about the lead plaintiff process and eligibility requirements here.
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 [email protected], or fill out the contact form above, to discuss your rights or interests with respect to these matters at no cost.
[WHAT SHOULD I KNOW ABOUT SECURITIES CLASS ACTIONS?]
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/
[email protected]
SOURCE: Kirby McInerney LLP