Capricor investors notified of securities fraud lawsuit over Deramiocel disclosures

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A PR Newswire notice from The Law Offices of Frank R. Cruz says Capricor Therapeutics investors who lost money may seek to lead a securities fraud class action tied to Deramiocel data and FDA approval risk.

A PR Newswire notice from The Law Offices of Frank R. Cruz says investors in Capricor Therapeutics, Inc. who say they lost money in CAPR may seek to lead a securities fraud class action over disclosures about Deramiocel and FDA approval risk.

The notice, published Sept. 2, 2026, says the lead plaintiff deadline is Sept. 28, 2026. It says investors who suffered losses do not need to take action to remain absent class members and may retain counsel of their choice.

The release says the lawsuit concerns statements made between Dec. 17, 2025, and July 26, 2026. It alleges that Capricor and related defendants made materially false or misleading statements and failed to disclose adverse facts about the company's business, operations and prospects.

Among the allegations in the notice are that Capricor changed the pre-specified statistical analysis plan used to evaluate Deramiocel clinical data, and that the Food and Drug Administration had not agreed to those changes before the company resubmitted the Deramiocel biologics license application, or BLA. The notice says that created a risk the FDA could conclude the clinical results did not provide substantial evidence of effectiveness, and that this posed a risk to approval of Deramiocel for Duchenne muscular dystrophy.

The release also says the defendants' positive statements about the company were allegedly misleading or lacked a reasonable basis. Those claims are made in the notice; the release does not include a court filing or response from Capricor in the text provided.

The notice gives contact information for The Law Offices of Frank R. Cruz, including a phone number, website and social media account. The source labels the item an attorney advertisement in some jurisdictions.

What happens next depends on whether investors seek appointment as lead plaintiff before the Sept. 28 deadline. The notice says investors may also keep their place in the case without taking immediate action.

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