Cytokinetics Announces European Medicines Agency Validation of Marketing Authorization Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Cytokinetics, Incorporated (CYTK)
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). “With regulatory filings for aficamten already under review in both the U.S. and China, the validation of the MAA marks an important milestone in bringing this potential medicine to even more patients with HCM worldwide,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to working with EMA in connection with their review of our application.” The MAA is supported by the results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clin
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- 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
- Cytokinetics Announces Sanofi Acquired Rights to Develop and Commercialize Aficamten in Greater ChinaGlobeNewswire
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