Capricor Therapeutics Inc Stock Price, News & Analysis

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.

Capricor Therapeutics (NASDAQ: CAPR) reported Q2 2025 financial results and provided key updates on its lead candidate Deramiocel. The company has scheduled a Type A meeting with the FDA to discuss the Deramiocel BLA resubmission path, following a Complete Response Letter. All 483 observations from the Pre-License Inspection have been resolved.

Financial highlights include a cash position of $122.8 million, expected to fund operations into Q4 2026. Q2 2025 resulted in a net loss of $25.9 million ($0.57 per share), compared to $11.0 million in Q2 2024. Operating expenses increased to $27.7 million from $15.6 million year-over-year.

The company's HOPE-3 Phase 3 trial completed its 12-month treatment period with topline data expected in Q4 2025. Additionally, the FDA cleared the IND for StealthX™ exosome-based vaccine, with NIAID initiating the Phase 1 clinical trial.

Capricor Therapeutics (NASDAQ: CAPR) has announced a scheduled Type A meeting with the FDA to discuss the regulatory pathway for their Biologics License Application (BLA) for Deramiocel, their lead cell therapy candidate for treating cardiomyopathy in Duchenne muscular dystrophy (DMD).

Due to this meeting, the company has rescheduled its Q2 2025 financial results release to August 11, 2025, after market close, with a conference call at 4:30 p.m. ET. Deramiocel, currently in late-stage development, has shown promising immunomodulatory and anti-fibrotic properties in preserving cardiac and skeletal muscle function in DMD patients. The company has an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the US and Japan.

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on cell and exosome-based therapeutics for rare diseases, will release its Q2 2025 financial results on August 13, 2025, after market close. The company will host a conference call at 4:30 p.m. ET the same day.

Capricor's lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne Muscular Dystrophy (DMD). The company has partnered with Nippon Shinyaku for exclusive commercialization rights in the US and Japan. Additionally, Capricor is developing its proprietary StealthX™ platform for targeted delivery of therapeutics.

Capricor Therapeutics (NASDAQ: CAPR) announced a webinar in collaboration with Parent Project Muscular Dystrophy (PPMD) scheduled for July 29, 2025, at 1:00 p.m. ET. The webinar will discuss the status of Capricor's Biologics License Application (BLA) for Deramiocel, their lead product candidate for treating Duchenne Muscular Dystrophy (DMD).

Deramiocel is an allogeneic cardiac-derived cell therapy in late-stage development, demonstrating immunomodulatory and anti-fibrotic properties for preserving cardiac and skeletal muscle function in muscular dystrophies. The company has secured an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel distribution in the United States and Japan, pending regulatory approval.