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Wolf Popper LLP Announces Investigation on Behalf of Capricor Therapeutics, Inc. Investors

1. Wolf Popper LLP is investigating claims for Capricor stock purchasers. 2. Capricor's FDA BLA for Deramiocel was not approved due to insufficient evidence. 3. Following the CRL, Capricor's stock plummeted 33% to $7.64. 4. Capricor's previous announcements had previously boosted stock to $9.10.

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FAQ

Why Very Bearish?

The FDA's Complete Response Letter (CRL) indicates significant hurdles for approval, potentially impacting investor confidence and future revenue analysis.

How important is it?

The article addresses crucial regulatory setbacks that directly influence Capricor's market perception and investors' approach to its stock.

Why Short Term?

The immediate impact of the CRL triggered a severe stock drop; further reactions could continue as new updates from Capricor emerge.

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SPPICNCESRNE
NEW YORK, July 14, 2025 (GLOBE NEWSWIRE) -- Wolf Popper LLP is investigating potential claims on behalf of purchasers of Capricor Therapeutics, Inc. (“Capricor”) common stock (NASDAQ: CAPR). Capricor is a clinical-stage drug company and its lead product candidate is Deramiocel, which is used to treat cardiomyopathy, a weakening of the heart in people with Duchenne muscular dystrophy. Capricor’s Phase 2 HOPE-2 clinical trial was completed in 2021. On September 24, 2024, Capricor announced it was filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the approval of Deramiocel. In the press release, Capricor said it had multiple in-depth meetings with the FDA. This announcement caused Capricor’s stock price to jump from $5.97 per share to $9.10 per share. On May 13, 2025, Capricor announced its first quarter 2025 results, referencing that the company “Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified….” Before the market opened on July 11, 2025, Capricor announced it received a Complete Response Letter [CRL] from the FDA regarding its BLA for Deramiocel. The press release said the FDA was unable to approve the BLA, citing that “the BLA does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data. The CRL also referenced certain outstanding items in Chemistry, Manufacturing, and Controls (CMC) section of the application.…” On this news, Capricor’s stock price fell $3.76 per share to $7.64 on July 11, 2025, down 33.0% on very heavy volume. Investors who suffered losses trading in Capricor common stock and who would like to discuss the investigation should contact Adam Savett at (212) 451-9655, or asavett@wolfpopper.com. Wolf Popper has successfully recovered billions of dollars for defrauded investors. Wolf Popper’s reputation and expertise have been repeatedly recognized by courts that have appointed the firm to major positions in securities litigation. For more information about Wolf Popper, please visit the Firm’s website at www.wolfpopper.com. May Be Considered Attorney Advertising in Certain Jurisdictions. Prior Results Do Not Guarantee a Similar Outcome. Wolf Popper LLPAdam Savett. Esq.845 Third AvenueNew York, NY 10022Tel.: (212) 451-9655Email: asavett@wolfpopper.com

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