Welcome to our dedicated page for Capricor Therapeutics news (Ticker: CAPR), a resource for investors and traders seeking the latest updates and insights on Capricor Therapeutics stock.
Capricor Therapeutics Inc (NASDAQ: CAPR) generates news primarily around its development of cell and exosome-based therapeutics for rare diseases, with a strong focus on Duchenne muscular dystrophy (DMD). The company’s announcements frequently highlight clinical trial milestones for its lead investigational therapy, Deramiocel (CAP-1002), as well as updates on its StealthX™ exosome platform.
Investors and followers of CAPR news can expect detailed coverage of clinical trial results and regulatory interactions. Recent communications include positive topline results from the pivotal Phase 3 HOPE-3 study of Deramiocel in DMD, information on primary and secondary endpoints such as Performance of Upper Limb (PUL v2.0) and left ventricular ejection fraction, and commentary from clinical investigators. Capricor also reports on its engagement with the U.S. Food and Drug Administration, including a Complete Response Letter for its Biologics License Application and subsequent Type A meeting to align on the role of HOPE-3 data in the regulatory pathway.
News items also cover corporate and financial developments, such as quarterly financial results, public offerings of common stock, and manufacturing readiness at the company’s GMP facility in San Diego, California. In addition, Capricor issues updates on scientific publications and conference presentations, including peer-reviewed work describing Deramiocel’s mechanism of action and data on scalable loading of therapeutic oligonucleotides into exosomes.
For those tracking CAPR, this news feed provides a centralized view of clinical, regulatory, scientific and financing updates directly related to Capricor’s programs. Regular review of these items can help readers follow the progress of Deramiocel in DMD, developments in the StealthX™ platform, and key corporate decisions that shape the company’s therapeutic pipeline.
Capricor Therapeutics (NASDAQ: CAPR) reported Q4 and full-year 2025 results and a corporate update. Key items: Deramiocel BLA is under FDA review with a PDUFA target action date of August 22, 2026. Phase 3 HOPE-3 met primary (PUL v2.0, p=0.03) and key cardiac (LVEF, p=0.04) endpoints. Cash and marketable securities were approximately $318.1 million as of December 31, 2025, supporting operations through 2027. San Diego GMP facility is operational and the company uplisted to the Nasdaq Global Select Market.
Capricor Therapeutics (NASDAQ: CAPR) reported additional Phase 3 HOPE-3 results presented at the 2026 MDA conference showing statistically significant functional and cardiac benefits of Deramiocel in Duchenne muscular dystrophy.
Key findings: reduced myocardial fibrosis by three segments (LGE, p=0.022), LVEF +3.3 percentage points in baseline cardiomyopathy subgroup (p=0.017), GST composite benefit (p=0.017), and ~83% slowing on the Duchenne Video Assessment eat-10 task (p=0.018). A Biologics License Application is under FDA review with a PDUFA date of August 22, 2026.
Capricor Therapeutics (NASDAQ: CAPR) announced the FDA has lifted its Complete Response Letter and resumed review of the Deramiocel BLA as a Class 2 resubmission, setting a PDUFA target action date of August 22, 2026. The company expects potential eligibility for a Priority Review Voucher upon approval.
Deramiocel is supported by positive HOPE-3 Phase 3 results and holds multiple designations including Orphan Drug, RMAT, ATMP, and Rare Pediatric Disease.
Capricor Therapeutics (NASDAQ: CAPR) will release fourth quarter and full year 2025 financial results after market close on March 12, 2026 and will host a conference call and webcast at 4:30 p.m. ET.
Replay will be available in the Investors section at capricor.com. Capricor highlighted lead candidate Deramiocel in late-stage development for Duchenne muscular dystrophy and its StealthX exosome platform. The company has an exclusive U.S. and Japan commercialization agreement with Nippon Shinyaku, subject to regulatory approval.
Capricor Therapeutics (NASDAQ: CAPR) announced that Phase 3 HOPE-3 results for Deramiocel in Duchenne muscular dystrophy were selected for a late-breaking oral presentation at the 2026 MDA Clinical and Scientific Conference on March 11, 2026 at 2:45 p.m. ET.
The company submitted the HOPE-3 clinical study report to the U.S. FDA to address items in a prior Complete Response Letter and to support the ongoing Biologics License Application review, including possible assignment of a new PDUFA target action date.
HOPE-3 randomized 106 subjects across ambulatory and non-ambulatory cohorts; Deramiocel holds multiple regulatory designations including Orphan, RMAT, ATMP, and Rare Pediatric Disease.
Capricor (NASDAQ: CAPR) said the FDA has requested the full HOPE-3 clinical study report (CSR) as part of its Biologics License Application (BLA) review for Deramiocel and did not ask for additional clinical studies or new patient data. The company is preparing the HOPE-3 CSR and plans to submit the requested materials in February 2026 to address the Complete Response Letter (CRL) received in July 2025, with the goal of supporting continued review and assignment of a new PDUFA target action date.
HOPE-3 randomized 106 subjects across ambulatory and non-ambulatory cohorts; Deramiocel holds multiple regulatory designations including Orphan, RMAT, ATMP, and Rare Pediatric Disease.
Capricor Therapeutics (NASDAQ: CAPR) and Parent Project Muscular Dystrophy will host a community webinar on December 17, 2025 at 1:00 p.m. ET to review positive topline results from Capricor’s Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy (DMD). The session will explain the HOPE-3 findings, discuss how the results inform ongoing regulatory discussions with the U.S. Food and Drug Administration, and allow participants to submit questions in advance.
Registration and a replay will be available on Parent Project Muscular Dystrophy’s website. Capricor noted Deramiocel and its StealthX platform remain investigational; Capricor has an exclusive U.S. and Japan commercialization agreement for Deramiocel with Nippon Shinyaku subsidiary NS Pharma, subject to regulatory approval.
Capricor Therapeutics (NASDAQ: CAPR) priced an underwritten public offering of 6,000,000 common shares at $25.00 per share, with gross proceeds expected to be $150 million before fees. The company granted underwriters a 30-day option to purchase up to an additional 900,000 shares at the public offering price, less underwriting discounts and commissions.
The offering is expected to close on or about December 8, 2025, subject to customary closing conditions. Net proceeds are intended for continued product development, manufacturing, working capital and general corporate purposes. The securities are offered under an effective Form S-3 shelf registration declared effective September 23, 2025.
Capricor Therapeutics (NASDAQ: CAPR) announced the commencement of a proposed underwritten public offering of its common stock on December 4, 2025. The company said it will grant underwriters a 30-day option to purchase additional shares equal to 15% of the aggregate shares sold.
The offering is subject to market conditions and may not be completed as proposed. Piper Sandler and Oppenheimer are joint book-running managers. Net proceeds are intended for product development, manufacturing, working capital and general corporate purposes. Securities will be offered under an effective Form S-3 (File No. 333-290179) declared effective on September 23, 2025.
Capricor Therapeutics (NASDAQ: CAPR) reported positive topline results from the pivotal Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy on Dec 3, 2025. The randomized, double-blind, placebo-controlled study (n=106) met its primary endpoint, PUL v2.0 (54% slowing vs placebo; p=0.029), and its key secondary cardiac endpoint, LVEF (91% preservation vs placebo; p=0.041). Results were statistically significant across type‑1‑error controlled secondary endpoints and safety was consistent with prior studies. The company plans to submit a response to its prior Complete Response Letter incorporating HOPE-3 data.