Capricor Therapeutics Inc Stock Price, News & Analysis

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.

Capricor Therapeutics (NASDAQ: CAPR) presented new preclinical data at AAEV 2025 (Nov 20–23, 2025) describing a scalable framework for loading therapeutic small interfering RNAs (siRNA) and phosphorodiamidate morpholino oligomers (PMO) into exosomes.

Key findings: engineered exosomes from 293F cells were loaded with siRNA and PMO using optimized electroporation; both scale-up and scale-out electroporation produced comparable loading efficiencies to small-volume electroporation; integrating the two approaches enabled manufacturing of significantly larger batches of loaded exosomes, offering a pathway to produce clinically relevant quantities to support future clinical development.

Capricor Therapeutics (NASDAQ: CAPR) reported third quarter 2025 results and a corporate update on Nov 10, 2025. Key near-term items include topline HOPE-3 Phase 3 results expected Q4 2025 and a planned BLA resubmission leveraging those data with an expected Type 2 review up to six months. The company completed an FDA Pre-License Inspection for its San Diego GMP facility and says all 483 observations were addressed and accepted.

Financial highlights: cash and marketable securities ~$98.6M (9/30/25), Q3 revenue $0, Q3 net loss ~$24.6M (or $0.54 per share). NIAID-sponsored Phase 1 StealthX trial has topline data anticipated Q1 2026, subject to NIAID completion.

Capricor Therapeutics (NASDAQ: CAPR) published a peer-reviewed Biomedicines study describing a novel in‑vitro potency assay for its lead cell therapy, Deramiocel.

The paper reports that cardiosphere‑derived cells (CDCs) and their exosomes suppressed collagen I and III gene expression in primary human fibroblasts, supporting an anti‑fibrotic mechanism. Results were consistent across more than 100 Deramiocel manufacturing lots. The assay was validated to assess lot‑to‑lot bioactivity and potency under quality‑controlled manufacturing conditions.

Deramiocel is in late‑stage development for Duchenne muscular dystrophy; topline Phase 3 HOPE‑3 data are expected in the mid‑fourth quarter of 2025, and Capricor plans to resubmit its BLA after responding to a CRL.

Capricor Therapeutics (NASDAQ: CAPR) will release its third quarter 2025 financial results for the period ended September 30, 2025, after market close on Monday, November 10, 2025. Management will host a webcast and conference call the same day at 4:30 p.m. ET with replay available on the company website.

Capricor highlighted its lead candidate Deramiocel in late-stage development for Duchenne muscular dystrophy and its preclinical StealthX exosome platform. The company noted an exclusive commercialization agreement for Deramiocel in the U.S. and Japan with Nippon Shinyaku (NS Pharma), subject to regulatory approval.

Capricor Therapeutics (NASDAQ: CAPR) provided a regulatory update following a Type A meeting with the FDA regarding its Biologics License Application (BLA) for Deramiocel, a cell therapy treatment for Duchenne Muscular Dystrophy (DMD). The FDA agreed that the completed HOPE-3 pivotal trial can serve as the additional study requested in the July 2025 Complete Response Letter (CRL).

Key developments include: The FDA will maintain PUL v2.0 as primary efficacy endpoint and consider left ventricular ejection fraction (LVEF) as key secondary endpoint. Topline data from HOPE-3, which enrolled 105 subjects, is expected in mid-Q4 2025. The company plans to submit this data within the current BLA, aiming for a label covering both cardiac and skeletal muscle function in DMD.

Prior to the CRL, most of the BLA had undergone review with no significant deficiencies identified, and all CMC items have been addressed. The FDA expressed commitment to regulatory flexibility in reviewing HOPE-3 trial data.

Capricor Therapeutics (NASDAQ: CAPR) has responded to the FDA's public posting of a Complete Response Letter (CRL) regarding their Biologics License Application (BLA) for Deramiocel, their cell therapy treatment for Duchenne muscular dystrophy (DMD) cardiomyopathy. The company was not pre-notified of the CRL posting from July 2025 and notes that their comprehensive preliminary response was not included in the FDA's public disclosure.

CEO Linda Marbán emphasized their commitment to transparency and continued collaboration with the FDA. The company awaits Type A meeting minutes later this quarter to determine next steps. Importantly, topline HOPE-3 data is expected in Q4 2025, which could influence the timing of their BLA resubmission.

Deramiocel (CAP-1002) has received multiple designations including Orphan Drug, RMAT, ATMP, and Rare Pediatric Disease Designation. The therapy has been tested in over 250 human subjects and documented in numerous peer-reviewed publications.

Capricor Therapeutics (NASDAQ: CAPR) has announced the initiation of a Phase 1 clinical trial for its StealthX™ exosome-based vaccine, with first subjects already dosed. The trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID) under HHS's Project NextGen, follows FDA clearance of the IND application.

The study includes four dosing arms and initially focuses on the SARS-CoV-2 spike protein, with plans for an additional arm incorporating the nucleocapsid protein pending FDA clearance. The company expects initial data in Q1 2026. StealthX™ represents a potential alternative to mRNA vaccines, featuring no adjuvants and utilizing native proteins for rapid adaptability to emerging targets.