Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA
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) ha annunciato un incontro di tipo A programmato con la FDA per discutere il percorso regolatorio della loro Domanda di Licenza Biologica (BLA) per Deramiocel, il loro principale candidato di terapia cellulare per il trattamento della cardiomiopatia nella distrofia muscolare di Duchenne (DMD).
A causa di questo incontro, la società ha riprogrammato la pubblicazione dei risultati finanziari del secondo trimestre 2025 al 11 agosto 2025, dopo la chiusura del mercato, con una conference call alle 16:30 ET. Deramiocel, attualmente in fase avanzata di sviluppo, ha dimostrato promettenti proprietà immunomodulatorie e antifibrotiche nel preservare la funzione cardiaca e muscolare scheletrica nei pazienti con DMD. La società ha un accordo esclusivo di commercializzazione con Nippon Shinyaku Co., Ltd. per Deramiocel negli Stati Uniti e in Giappone.
Capricor Therapeutics (NASDAQ: CAPR) ha anunciado una reunión programada de Tipo A con la FDA para discutir la vía regulatoria de su Solicitud de Licencia Biológica (BLA) para Deramiocel, su principal candidato en terapia celular para tratar la miocardiopatía en la distrofia muscular de Duchenne (DMD).
Debido a esta reunión, la empresa ha reprogramado la publicación de sus resultados financieros del segundo trimestre de 2025 para el 11 de agosto de 2025, después del cierre del mercado, con una llamada de conferencia a las 4:30 p.m. ET. Deramiocel, actualmente en etapa avanzada de desarrollo, ha mostrado prometedoras propiedades inmunomoduladoras y antifibróticas para preservar la función cardíaca y muscular esquelética en pacientes con DMD. La compañía tiene un acuerdo exclusivo de comercialización con Nippon Shinyaku Co., Ltd. para Deramiocel en EE. UU. y Japón.
Capricor Therapeutics (NASDAQ: CAPR)는 FDA와 예정된 Type A 미팅을 발표하여, 듀센 근이영양증(DMD) 심근병증 치료를 위한 주요 세포 치료 후보인 Deramiocel의 생물학적 제제 허가 신청서(BLA)에 대한 규제 경로를 논의할 예정입니다.
이 미팅으로 인해 회사는 2025년 2분기 재무 결과 발표를 2025년 8월 11일 장 마감 후로 연기했으며, 오후 4시 30분(동부 시간)에 컨퍼런스 콜을 진행할 예정입니다. 현재 후기 개발 단계에 있는 Deramiocel은 DMD 환자의 심장 및 골격근 기능 보존에 있어 면역조절 및 항섬유화 특성이 유망하게 나타났습니다. 회사는 미국과 일본에서 Deramiocel의 독점 상업화 계약을 Nippon Shinyaku Co., Ltd.와 체결했습니다.
Capricor Therapeutics (NASDAQ : CAPR) a annoncé une réunion de type A programmée avec la FDA afin de discuter de la voie réglementaire pour leur demande d'autorisation de mise sur le marché biologique (BLA) concernant Deramiocel, leur principal candidat en thérapie cellulaire pour le traitement de la cardiomyopathie dans la dystrophie musculaire de Duchenne (DMD).
En raison de cette réunion, la société a reprogrammé la publication de ses résultats financiers du deuxième trimestre 2025 au 11 août 2025, après la clôture du marché, avec une conférence téléphonique à 16h30 ET. Deramiocel, actuellement en phase avancée de développement, a montré des propriétés immunomodulatrices et antifibrotiques prometteuses pour préserver la fonction cardiaque et musculaire squelettique chez les patients atteints de DMD. La société a conclu un accord exclusif de commercialisation avec Nippon Shinyaku Co., Ltd. pour Deramiocel aux États-Unis et au Japon.
Capricor Therapeutics (NASDAQ: CAPR) hat ein geplantes Type-A-Meeting mit der FDA angekündigt, um den regulatorischen Weg für ihre Biologics License Application (BLA) für Deramiocel zu besprechen, ihren führenden Zelltherapie-Kandidaten zur Behandlung der Kardiomyopathie bei Duchenne-Muskeldystrophie (DMD).
Aufgrund dieses Treffens hat das Unternehmen die Veröffentlichung der Finanzergebnisse für das 2. Quartal 2025 auf den 11. August 2025, nach Börsenschluss, verschoben, mit einer Telefonkonferenz um 16:30 Uhr ET. Deramiocel, derzeit in der späten Entwicklungsphase, hat vielversprechende immunmodulatorische und antifibrotische Eigenschaften gezeigt, die zur Erhaltung der Herz- und Skelettmuskel-Funktion bei DMD-Patienten beitragen. Das Unternehmen hat eine exklusive Vermarktungsvereinbarung mit Nippon Shinyaku Co., Ltd. für Deramiocel in den USA und Japan.
- Type A meeting secured with FDA to discuss BLA pathway for Deramiocel
- Exclusive commercialization agreement in place with Nippon Shinyaku for US and Japan markets
- Deramiocel shows promising results in preserving cardiac and skeletal muscle function
- Deramiocel still requires regulatory approval with no guaranteed timeline
- Financial results release delayed due to FDA meeting
Insights
FDA Type A meeting signals potential BLA issues for Capricor's DMD therapy Deramiocel, suggesting regulatory hurdles ahead.
The scheduling of a Type A meeting with the FDA regarding Capricor's Biologics License Application (BLA) for Deramiocel is a significant regulatory development that warrants close attention. Type A meetings are specifically requested when there are stalled product development programs or disagreements with the FDA that require resolution. Unlike routine Type B or C meetings, Type A meetings indicate potential regulatory obstacles that need urgent addressing.
In the context of Capricor's BLA for Deramiocel, this suggests the FDA may have identified substantive issues during their review process. The company's decision to reschedule their earnings call to follow this meeting further underscores its importance - management likely wants to incorporate the meeting's outcomes into their investor communications.
For Duchenne muscular dystrophy patients, the regulatory pathway for Deramiocel is particularly critical. DMD is a devastating rare disease with limited treatment options, and Deramiocel's allogeneic cardiac-derived cell therapy represents a novel therapeutic approach focusing on immunomodulatory and anti-fibrotic actions to preserve cardiac and skeletal muscle function.
The Type A meeting will likely determine whether additional data is required, if there are manufacturing concerns, or if the clinical endpoints achieved are sufficient for approval. The outcome could range from minor clarifications to requests for additional clinical trials, which would significantly impact the timeline to potential market approval.
– Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET –
SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the regulatory path for 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).
To accommodate this meeting, the Company has rescheduled the release of its financial results for the second quarter ended June 30, 2025, to Monday, August 11, 2025, after the market close. Management will host a webcast and conference call at 4:30 p.m. ET on the same day to review the financial results and provide a corporate update.
| Title: | Capricor Therapeutics Second Quarter 2025 Financial Results and Recent Corporate Update Conference Call and Webcast |
| Date: | Monday, August 11, 2025 |
| Time: | 4:30 p.m. ET |
| Conference Call Details: | Toll-Free: 1-800-717-1738 International: 1-646-307-1865 Conference ID: 90328 Participants can use the guest dial-in numbers above and be answered by an operator, or click the Call me™ link for instant telephone access to the event. |
| Webcast: | Click here to access the live webcast |
A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.
About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Deramiocel, an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown Deramiocel to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. Deramiocel is currently in late-stage development for the treatment of Duchenne Muscular Dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics to potentially treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and Twitter.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission on May 14, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
Capricor has entered into an agreement for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.
For more information, please contact:
Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204
Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755
FAQ
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