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Aficamten FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 6, 2024.

FDA Approved: No
Generic name: aficamten
Company: Cytokinetics, Incorporated
Treatment for: Hypertrophic Cardiomyopathy

Aficamten is a selective, small molecule cardiac myosin inhibitor in development for the treatment of obstructive hypertrophic cardiomyopathy.

Development timeline for aficamten

DateArticle
Dec  2, 2024Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Dec 27, 2023Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy
Feb  1, 2022Cytokinetics Announces Positive Topline Results from Cohort 3 of REDWOOD-HCM
Dec  9, 2021Cytokinetics Announces Receipt of Breakthrough Therapy Designation from FDA for Aficamten
Jan 11, 2021Cytokinetics Granted Orphan Drug Designation for CK-3773274 for the Treatment of Hypertrophic Cardiomyopathy

Further information

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