Biotech company Cytokinetics is aiming for an early Q1 2026 launch of aficamten in the United States, as the Food and Drug Administration's review progresses and significant clinical achievements draw near.
The Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for Cytokinetics' New Drug Application (NDA) for aficamten, a potential treatment for patients with obstructive hypertrophic cardiomyopathy (oHCM). The new PDUFA date is set for December 26, 2025, providing more time for the FDA to review the NDA.
The extension follows a late-cycle review meeting, the date of which remains undisclosed. The CEO of Cytokinetics, Robert I. Blum, has expressed optimism about the development process of aficamten.
The FDA's extension is based on the company's submission of a required Risk Evaluation and Mitigation Strategy (REMS), with no additional clinical data requested. This is generally considered a positive indicator towards approval.
The clinical data supporting aficamten, notably from the MAPLE-HCM trial, show that it has superior efficacy compared with metoprolol in improving exercise capacity and reducing left ventricular outflow tract obstruction. This potential approval as a standard-of-care therapy could mark a significant milestone in the treatment of oHCM.
Financially, Cytokinetics reported robust cash reserves (~$1 billion) at the end of June 2025 to support commercialization efforts upon potential approval, expected early 2026.
Global regulatory activities are also underway, with the European Medicines Agency (EMA) and the Chinese Center for Drug Evaluation (CDE) reviewing aficamten applications. The EMA decision is expected in early 2026.
It is important to note that the extension of the PDUFA date is subject to the usual conditions and requirements of the FDA review process. The extension does not guarantee FDA approval of aficamten for the treatment of oHCM.
The latest update provides a clear indication that the FDA's formal review is actively progressing, with an anticipated decision by the end of December 2025, following the late-cycle meeting in September 2025. This development is significant as it brings us one step closer to potentially offering a new treatment option for patients with oHCM.
[1] FDA Extends PDUFA Action Date for Aficamten. (2023). Retrieved from https://www.cytokinetics.com/news-events/press-releases/detail/2025/fda-extends-pdufa-action-date-for-aficamten
[2] Cytokinetics Reports Second Quarter 2025 Financial Results and Provides Business Update. (2025). Retrieved from https://www.cytokinetics.com/news-events/press-releases/detail/2025/cytokinetics-reports-second-quarter-2025-financial-results-and-provides-business-update
[3] Cytokinetics Announces PDUFA Action Date Extension for Aficamten. (2023). Retrieved from https://www.cytokinetics.com/news-events/press-releases/detail/2023/cytokinetics-announces-pdufa-action-date-extension-for-aficamten
[4] Aficamten PDUFA Action Date Extended to December 26, 2025. (2023). Retrieved from https://www.pharmatimes.com/news/aficamten_pdufa_action_date_extended_to_december_26_2025_1566892
- With the FDA extending the PDUFA date for aficamten to December 26, 2025, this could mark a significant step towards the approval of a new medical-condition treatment for chronic-diseases like obstructive hypertrophic cardiomyopathy, thereby contributing to the health-and-wellness industry's ongoing progress in therapies-and-treatments.
- The ongoing review of aficamten by global regulatory bodies such as the European Medicines Agency and the Chinese Center for Drug Evaluation indicates a growing interest in the potential of this treatment for various medical-conditions, particularly chronic-diseases like obstructive hypertrophic cardiomyopathy, emphasizing the need for continued advancement in science and health-and-wellness developments.
