Capricor Therapeutics, Inc.

Case Overview
59 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 09/15/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Capricor Therapeutics, Inc. |
Court: | Court: Southern District of California |
Case Number: | Case Number: 3:25cv01815 |
Class Period: | Class Period: 10/09/2024 - 07/10/2025 |
Ticker: | Ticker: CAPR |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of California on behalf of those who acquired Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ:CAPR) securities during the period of, inclusive (“the Class Period”). Investors have until September 15, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
On May 5, 2025, Capricor issued a press release announcing it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate drug deramiocel. The Company announced that the review committee found no significant deficiencies and that the package was on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA confirmed its intent to hold an advisory committee meeting. On this news, the price of Capricor shares declined by approximately 29.13%, from $10.30 per share on May 5, 2025 to $7.30 per share on May 6, 2025.
On July 11, 2025, Capricor announced that it received a Complete Response Letter (CRL) from FDA the denying the Company’s Biologics License Application (BLA) for deramiocel. The CRL cited Capricor’s failure to meet the requirement for evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. On this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.
According to the lawsuit, Capricor’s statements regarding its ability to obtain a BLA for deramiocel from the FDA were misleading. The Company provided overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.
On May 5, 2025, Capricor issued a press release announcing it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate drug deramiocel. The Company announced that the review committee found no significant deficiencies and that the package was on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA confirmed its intent to hold an advisory committee meeting. On this news, the price of Capricor shares declined by approximately 29.13%, from $10.30 per share on May 5, 2025 to $7.30 per share on May 6, 2025.
On July 11, 2025, Capricor announced that it received a Complete Response Letter (CRL) from FDA the denying the Company’s Biologics License Application (BLA) for deramiocel. The CRL cited Capricor’s failure to meet the requirement for evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. On this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.
According to the lawsuit, Capricor’s statements regarding its ability to obtain a BLA for deramiocel from the FDA were misleading. The Company provided overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel.