Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy
Cytokinetics (CYTK) announced that the FDA has extended the PDUFA date for aficamten, its drug candidate for obstructive hypertrophic cardiomyopathy (oHCM), to December 26, 2025. The extension comes after the FDA requested Cytokinetics to submit a Risk Evaluation and Mitigation Strategy (REMS), which was deemed a Major Amendment to the New Drug Application (NDA).
The FDA's decision resulted in a standard three-month extension from the original PDUFA date. Notably, no additional clinical data or studies were requested. The company maintains confidence in aficamten's benefit-risk profile and expects a differentiated label upon potential FDA approval.
Cytokinetics (CYTK) ha annunciato che la FDA ha prorogato la data PDUFA per aficamten, il suo candidato farmaco per la cardiomiopatia ipertrofica ostruttiva (oHCM), al 26 dicembre 2025. L'estensione è stata richiesta dopo che la FDA ha chiesto a Cytokinetics di presentare una Strategia di Valutazione e Mitigazione del Rischio (REMS), considerata una modifica importante alla Domanda di Nuovo Farmaco (NDA).
La decisione della FDA ha comportato una proroga standard di tre mesi rispetto alla data PDUFA originale. È importante sottolineare che non sono stati richiesti ulteriori dati clinici o studi. L'azienda mantiene fiducia nel profilo beneficio-rischio di aficamten e prevede un'etichetta differenziata in caso di approvazione da parte della FDA.
Cytokinetics (CYTK) anunció que la FDA ha extendido la fecha PDUFA para aficamten, su candidato a medicamento para la miocardiopatía hipertrófica obstructiva (oHCM), hasta el 26 de diciembre de 2025. La extensión se produjo después de que la FDA solicitara a Cytokinetics presentar una Estrategia de Evaluación y Mitigación de Riesgos (REMS), considerada una enmienda mayor a la Solicitud de Nuevo Medicamento (NDA).
La decisión de la FDA resultó en una extensión estándar de tres meses desde la fecha PDUFA original. Cabe destacar que no se solicitaron datos clínicos adicionales ni estudios. La compañía mantiene la confianza en el perfil beneficio-riesgo de aficamten y espera una etiqueta diferenciada tras una posible aprobación de la FDA.
Cytokinetics (CYTK)는 FDA가 폐쇄성 비대성 심근병증(oHCM) 치료 후보 약물인 aficamten의 PDUFA 날짜를 2025년 12월 26일로 연장했다고 발표했습니다. 이번 연장은 FDA가 Cytokinetics에 위험 평가 및 완화 전략(REMS) 제출을 요청했기 때문이며, 이는 신약 신청서(NDA)에 대한 주요 수정으로 간주되었습니다.
FDA의 결정으로 원래 PDUFA 날짜에서 표준 3개월 연장이 이루어졌습니다. 추가 임상 데이터나 연구는 요청되지 않았습니다. 회사는 aficamten의 이익-위험 프로파일에 대한 신뢰를 유지하며, FDA 승인 시 차별화된 라벨을 기대하고 있습니다.
Cytokinetics (CYTK) a annoncé que la FDA a prolongé la date PDUFA pour aficamten, son candidat médicament pour la cardiomyopathie hypertrophique obstructive (oHCM), jusqu'au 26 décembre 2025. Cette extension fait suite à la demande de la FDA à Cytokinetics de soumettre une Stratégie d'Évaluation et de Réduction des Risques (REMS), considérée comme une modification majeure de la demande de nouveau médicament (NDA).
La décision de la FDA a entraîné une prolongation standard de trois mois par rapport à la date PDUFA initiale. Notamment, aucune donnée clinique supplémentaire ni étude n'ont été demandées. L'entreprise reste confiante dans le profil bénéfice-risque d'aficamten et s'attend à un label différencié en cas d'approbation par la FDA.
Cytokinetics (CYTK) gab bekannt, dass die FDA das PDUFA-Datum für aficamten, den Arzneimittelkandidaten gegen obstruktive hypertrophe Kardiomyopathie (oHCM), auf den 26. Dezember 2025 verlängert hat. Die Verlängerung erfolgte, nachdem die FDA Cytokinetics aufgefordert hatte, eine Risiko-Evaluations- und Minderungsstrategie (REMS) einzureichen, die als wesentliche Änderung des Zulassungsantrags (NDA) angesehen wurde.
Die Entscheidung der FDA führte zu einer standardmäßigen dreimonatigen Verlängerung gegenüber dem ursprünglichen PDUFA-Datum. Es wurden keine zusätzlichen klinischen Daten oder Studien angefordert. Das Unternehmen bleibt zuversichtlich bezüglich des Nutzen-Risiko-Profils von aficamten und erwartet bei einer möglichen FDA-Zulassung ein differenziertes Etikett.
- No additional clinical data or studies requested by FDA
- Company maintains confidence in aficamten's benefit-risk profile
- Constructive engagement with FDA continues
- PDUFA date delayed by three months to December 26, 2025
- Additional REMS requirements could impact drug commercialization
SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS).
Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA.
“We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to continuing our constructive engagement with the FDA regarding the NDA for aficamten.”
About Cytokinetics
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that aficamten will be approved with a differentiated label and REMS. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA’s on-going review of our NDA for aficamten in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
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