Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Cytokinetics, Incorporated (CYTK)
Last cytokinetics, incorporated earnings: 3/3 04:00 pm
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Source: GlobeNewswire
PDUFA Target Action Date Set for September 26, 2025 SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025. The FDA is not currently planning to hold an advisory committee meeting to discuss the application. “The NDA acceptance for aficamten by FDA is a significant milestone that moves our company another step closer to hopefully translating our pioneering science to the potential benefit of patients suffering from obstructive HCM. The results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial, which form the foundation of the NDA, demonstrated that aficamten has
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News
- Cytokinetics to Present at the 43rd Annual J.P. Morgan Healthcare ConferenceGlobeNewswire
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)GlobeNewswire
- Cytokinetics Announces European Medicines Agency Validation of Marketing Authorization Application for Aficamten for the Treatment of Obstructive Hypertrophic CardiomyopathyGlobeNewswire
- Why Cytokinetics Stock Was a Nearly 5% Winner Today [Yahoo! Finance]Yahoo! Finance
- Cytokinetics, Incorporated (NASDAQ: CYTK) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $120.00 price target on the stock.MarketBeat
CYTK
Earnings
- 11/6/24 - Miss
CYTK
Sec Filings
- 12/16/24 - Form 4
- 12/16/24 - Form 8-K
- 12/16/24 - Form 144
- CYTK's page on the SEC website