Capricor Therapeutics, Inc. (CAPR)
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
NASDAQHealth CareBiotechnologySnapshot 2026-09-04
QuarterlyIQ Insights · CAPR
Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
by reference. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. CAPRICOR THERAPEUTICS, INC. Date: July 14, 2026 By: /s/ Linda Marbán, Ph.D. Linda Marbán, Ph.D. Chief Executive Officer 3
Entry into a Material Definitive Agreement. On July 9, 2026, Capricor Therapeutics, Inc. (“Capricor”) entered into a Lease Agreement (the “Lease”) with ARE-SD Region No. 39 Owner, LLC (“Landlord”) for approximately 171,000 rentable square feet located at 9625 Towne Centre Drive, San Diego, California, to be used as Capricor’s new headquarters, including expanded manufacturing cleanrooms, research and development laboratory, administrative offices and other related uses. The term of the Leas…
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Regulation FD Disclosure. On May 7, 2026, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) announced that it has filed a Complaint for Equitable Relief (the “Complaint”) and Application for Preliminary Injunction (collectively, the “Lawsuit”) in the Superior Court of New Jersey, Chancery Division, Bergen County. A copy of the press release has been attached as Exhibit 99.1 hereto and is incorporated herein by reference. A copy of the Complaint has been attached as Exhibit 99.2 he…
Other Events. On May 7, 2026, Capricor announced that it has filed a Complaint for Equitable Relief and Application for Preliminary Injunction in the Superior Court of New Jersey, Chancery Division, Bergen County (the “Lawsuit”). The Lawsuit alleges a fundamental pricing flaw in the Commercialization and Distribution Agreement dated January 24, 2022, between the Company and Nippon Shinyaku Co., Ltd. (the “U.S. Distribution Agreement”). The Lawsuit also seeks relief from Nippon Shinyaku Co.…
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Regulation FD Disclosure. On March 10, 2026, Capricor Therapeutics, Inc. (the “Company” or “Caprcior”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has lifted the previously issued Complete Response Letter (“CRL”) and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. A copy of the press release is a…
Other Events. As disclosed above, the FDA has lifted the previously issued CRL and resumed review of the Company’s BLA seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of DMD cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026. This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities L…
Other Events. On December 5, 2025, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), entered into an underwriting agreement (the “Underwriting Agreement”) with Piper Sandler & Co. and Oppenheimer & Co. Inc. as representatives of the underwriters (the “Underwriters”), pursuant to which the Company agreed to sell and issue, in a public offering (the “Offering”), an aggregate of 6,000,000 shares of common stock, $0.001 par value per share, of the Company (the “Common Stock”)…
Other Events. As disclosed above, the Company announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial. HOPE-3 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating Deramiocel in boys and young men with Duchenne muscular dystrophy. The study randomized 106 participants across 20 leading U.S. clinical sites. Participants received intravenous Deramiocel at 150 million cells per infusion or placebo every three months for a 12-month period.…
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Regulation FD Disclosure. On July 11, 2025, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) issued a press release announcing that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In the CRL, the FDA stated that it had completed its review of…
The filing is about the approval of a new equity incentive plan, not a management change.
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Director — Mr. Earl Collier: Mr. Earl Collier will not stand for re-election to the Board of Directors.
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.
Entry into a Material Definitive Agreement. On October 16, 2024, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), entered into an underwriting agreement (the “Underwriting Agreement”) with Piper Sandler & Co. and Oppenheimer & Co. Inc. as representatives of the underwriters (the “Underwriters”), pursuant to which the Company agreed to sell and issue, in a public offering (the “Offering”), an aggregate of 4,412,000 shares of common stock, $0.001 par value per share, of the…
Results of Operations and Financial Condition. The information set below under “Recent Developments – Preliminary balance of cash, cash equivalents and short-term investments” in
Other Events. Recent Developments Deramiocel for the treatment of Duchenne muscular dystrophy (DMD) Following recent meetings with the U.S. Food and Drug Administration (“FDA”), Capricor Therapeutics, Inc. (“Capricor” or the “Company”) announced its intent to file a Biologics License Application (“BLA”) based on existing cardiac and natural history data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (“DMD”) cardiomyopathy. ● Capricor commenced the filing of a…
Entry into a Material Definitive Agreement. Commercialization and Distribution Binding Term Sheet On September 16, 2024, Capricor Therapeutics, Inc. (the “Company” or “Capricor”) entered into a Binding Term Sheet (the “Term Sheet”) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”) for the commercialization and distribution of deramiocel, the Company’s lead product candidate, for the treatment of Duchenne muscular dystrophy in the European region, as defined in the T…
Regulation FD Disclosure. On September 17, 2024, the Company issued a press release announcing the Term Sheet and the Private Placement. A copy of the press release has been furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
in its entirety, on September 16, 2024, the Company sold the Shares to an “accredited investor,” as that term is defined in the Securities Act of 1933, as amended (the “Securities Act”), and in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act and corresponding provisions of state securities or “blue sky” laws. Nippon Shinyaku represented to the Company that it was an “accredited inve…
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