Capricor investors face Sept. 28 deadline in securities fraud lawsuit
The press release says the case concerns alleged misleading statements about Deramiocel and the FDA review process.
A law firm press release says investors who lost money in Capricor Therapeutics Inc. may seek to lead an ongoing securities fraud class action, with a lead plaintiff deadline of Sept. 28, 2026.
The release says the proposed class action concerns alleged misleading statements and omissions tied to Capricor’s Deramiocel treatment and its FDA approval process.
According to the release from the Law Offices of Howard G. Smith, the complaint covers the period from Dec. 17, 2025, through July 26, 2026. It alleges the company changed a pre-specified statistical analysis plan used to evaluate Deramiocel clinical data, that the FDA had not agreed to those changes before Capricor resubmitted the Deramiocel biologics license application, and that there was a significant risk the agency could conclude the results did not provide substantial evidence of effectiveness.
The release also alleges there was substantial risk to regulatory approval of Deramiocel for Duchenne muscular dystrophy and that positive statements about the company’s business, operations and prospects were materially misleading or lacked a reasonable basis.
The source is an attorney advertising press release published by PR Newswire on Aug. 6, 2026. It does not include an independent court filing, company response or regulatory document, and it frames the matter as an opportunity for investors with substantial losses to contact the firm about serving as lead plaintiff. The release says class members do not need to act immediately and may retain counsel of their choice or remain absent class members.
The notice gives the Bensalem, Pennsylvania law office’s contact information and says investors should respond before the Sept. 28 deadline if they want to be considered for lead plaintiff status. No further court action was described in the source text.
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Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.
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