Faruqi & Faruqi seeks lead plaintiff in Capricor securities case
The firm says the case concerns alleged misleading statements and omissions about Deramiocel, FDA feedback and the drug’s regulatory outlook.
Faruqi & Faruqi, LLP said it is investigating claims against Capricor Therapeutics, Inc. and is seeking lead-plaintiff participation in a federal securities class action over alleged misleading statements and omissions tied to Deramiocel and the drug’s FDA review prospects.
The notice, dated Sept. 4, says investors who purchased or acquired Capricor securities between Dec. 17, 2025, and July 26, 2026, may be eligible to participate. It says the deadline to seek lead-plaintiff status is Sept. 28, 2026.
According to the PR Newswire notice, Capricor shares fell $12.70, or 64%, to $7.00 on July 27, 2026, after the FDA released briefing documents ahead of an advisory committee meeting. The notice also says the stock fell $2.38, or 36%, to $4.19 on July 30, 2026, after the advisory committee vote.
In its summary of the complaint, the notice says Capricor and certain officers or directors allegedly made false or misleading statements, or failed to disclose, that the company had changed the pre-specified statistical analysis plan for Deramiocel, that the FDA had not agreed to those changes before the biologics license application was resubmitted, and that the agency could conclude the clinical results did not provide substantial evidence of effectiveness.
The notice also says the complaint alleges there was substantial risk to approval of Deramiocel for Duchenne muscular dystrophy and that positive statements about the company’s business, operations and prospects lacked a reasonable basis.
The notice cites FDA briefing documents released before the July 29 advisory committee meeting, saying the agency wrote that the “benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness.” It says the advisory committee later held a non-binding 9-3 vote and concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy.
Faruqi & Faruqi’s notice says lead plaintiff is the class member with the largest financial interest who is adequate and typical of the class. It says investors can ask the court to appoint them as lead plaintiff or do nothing and remain absent class members, and that their ability to share in any recovery is not affected by whether they seek that role.
The notice gives investors who want more information the website www.faruqilaw.com/CAPR and lists attorney Josh Wilson at 877-247-4292 and 212-983-9330 ext. 1310.
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Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.
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