Welcome to our dedicated page for Capricor Therapeutics SEC filings (Ticker: CAPR), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Capricor Therapeutics filings document a Delaware biotechnology issuer developing cell and exosome-based therapeutics, including Deramiocel for Duchenne muscular dystrophy. Its 8-K reports record quarterly and annual financial results, FDA communications tied to the Deramiocel Biologics License Application, Regulation FD disclosures, and material-event reporting for litigation-related actions.
Proxy materials address board elections, executive compensation, equity awards, shareholder voting matters, and other governance disclosures. The filing record also identifies CAPR common stock, par value $0.001 per share, as a Nasdaq-listed security and provides formal disclosure around operating results, capital structure, and public-company status.
Capricor Therapeutics EVP and General Counsel Karen Krasney exercised stock options to acquire 2,500 shares of common stock at an exercise price of $1.39 per share. These options were originally granted on January 3, 2017 and adjusted for a 1-for-10 reverse split and a later option reprice.
Following the exercise, Krasney directly holds 30,547 shares of Capricor common stock. The option grant vested in equal monthly installments, with 1/48th of the award vesting on the first day of each month beginning on February 1, 2017, and this filing reflects the full exercise of the remaining 2,500-share option position.
Capricor Therapeutics, Inc. details its strategy as a biotechnology company developing cell and exosome-based therapies, led by Deramiocel for Duchenne muscular dystrophy (DMD). A Biologics License Application for Deramiocel is under FDA review with a PDUFA target action date of August 22, 2026, following a Complete Response Letter and Class 2 resubmission.
The Phase 3 HOPE-3 trial in DMD met its primary endpoint, showing 54% slowing of progression on PUL v2.0 (p=0.029) and a key cardiac endpoint with 91% slowing of LVEF decline (p=0.041), alongside supportive functional and cardiac MRI data. Earlier HOPE-2 and HOPE-Duchenne studies and a long-term open-label extension also suggest preserved skeletal and cardiac function with an acceptable safety profile.
Capricor has built a global commercialization framework with Nippon Shinyaku, including U.S. and Japan distribution agreements and a European binding term sheet. Payments include a $30 million U.S. upfront plus multiple development and sales milestones (up to $605 million in U.S. sales milestones), a $12 million Japan upfront with up to about $89 million in milestones, and a European structure featuring a $20 million upfront and up to $715 million in potential milestones, all paired with double-digit revenue shares.
Capricor Therapeutics reported fourth-quarter and full-year 2025 results alongside a corporate update centered on its lead DMD therapy, Deramiocel. The company’s Biologics License Application is under FDA review with a PDUFA target action date of August 22, 2026.
Cash, cash equivalents and marketable securities were about $318.1 million as of December 31, 2025, up from about $151.5 million a year earlier, driven by a public offering that generated roughly $161.9 million in net proceeds and $75.1 million raised via its at-the-market program.
Revenues were $0 in both the fourth quarter and full year 2025, versus about $11.1 million and $22.3 million in 2024, after fully recognizing prior milestone payments from Nippon Shinyaku by year-end 2024. Total operating expenses rose to about $108.1 million for 2025, leading to a net loss of roughly $105.0 million, or $2.26 per share. Management believes its current cash position can fund operations through 2027 while it advances Deramiocel and its exosome platform.
Capricor Therapeutics reported fourth-quarter and full-year 2025 results alongside a corporate update centered on its lead DMD therapy, Deramiocel. The company’s Biologics License Application is under FDA review with a PDUFA target action date of August 22, 2026.
Cash, cash equivalents and marketable securities were about $318.1 million as of December 31, 2025, up from about $151.5 million a year earlier, driven by a public offering that generated roughly $161.9 million in net proceeds and $75.1 million raised via its at-the-market program.
Revenues were $0 in both the fourth quarter and full year 2025, versus about $11.1 million and $22.3 million in 2024, after fully recognizing prior milestone payments from Nippon Shinyaku by year-end 2024. Total operating expenses rose to about $108.1 million for 2025, leading to a net loss of roughly $105.0 million, or $2.26 per share. Management believes its current cash position can fund operations through 2027 while it advances Deramiocel and its exosome platform.
Capricor Therapeutics, Inc. reported that the U.S. FDA has lifted a prior Complete Response Letter and resumed review of its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy. The resubmission is classified as Class 2, with a PDUFA target action date of August 22, 2026.
The company submitted additional data and documentation from the HOPE-3 clinical trial, and the FDA has not identified any potential review issues in its response. Capricor also expects to be eligible to receive a Priority Review Voucher if Deramiocel is approved.
Capricor Therapeutics reports Schedule 13G ownership disclosures showing Suvretta Capital Management, LLC and affiliated parties hold multi‑percent stakes. Suvretta reports 3,417,891 shares (6.6%), Averill Master Fund, Ltd. reports 2,917,420 shares (5.6%), and Aaron Cowen reports 3,417,891 shares (6.6%). The filing states these shares are directly owned by advisory clients of Suvretta Capital Management, and the reported holdings reflect shared voting and dispositive power for the listed reporting persons.
Highbridge Capital Management, LLC reports beneficial ownership of 1,200,000 shares of Capricor Therapeutics common stock, representing 2.3% of the class. These shares are issuable upon exercise of warrants held by funds it advises.
The 2.3% figure is based on 51,716,975 shares outstanding as of December 5, 2025, after completion of the issuer’s offering and assuming warrant exercise. Highbridge states the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Capricor Therapeutics.
Tang Capital Management and related entities have disclosed a significant ownership position in Capricor Therapeutics, Inc. common stock. The group reports beneficial ownership of 3,399,900 shares of Capricor common stock, representing 6.6% of the outstanding shares as of the referenced date. All 3,399,900 shares are reported with shared voting and shared dispositive power, and no shares are reported with sole voting or dispositive power.
Within the group, Tang Capital Partners, LP reports 2,337,350 shares, or 4.5% of the class, and Tang Capital Partners International, LP reports 1,062,550 shares, or 2.1% of the class. Kevin Tang is identified as sharing voting and dispositive power with the Tang Capital entities. The filing is made on Schedule 13G, and the reporting persons certify that the securities were not acquired and are not held for the purpose or effect of changing or influencing control of Capricor Therapeutics.