SOUTH SAN FRANCISCO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment. AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial of CK-4021586 (CK-586) in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejec ...

PDUFA Target Action Date for Aficamten Set for September 26, 2025;Commercial Launch Preparations Underway for First Potential Approval Five-Year Aspirations Outline Corporate Strategies to Becoming Leading Muscle Biology Specialty Biopharma Company SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) today provided guidance for corporate milestones expected to occur in 2025 and outlined its aspirational Vision 2030, five-year strategic objectives designed to prope ...

PDUFA Target Action Date for Aficamten Set for September 26, 2025;Commercial Launch Preparations Underway for First Potential Approval Five-Year Aspirations Outline Corporate Strategies to Becoming Leading Muscle Biology Specialty Biopharma Company SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Inc. (NASDAQ:CYTK) today provided guidance for corporate milestones expected to occur in 2025 and outlined its aspirational Vision 2030, five-year strategic objectives designed to prope ...

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 9:00 AM Pacific Time in the Borgia Room of the Westin St. Francis Hotel in San Francisco, CA. Interested parties may access the live webcast of the presentation by visiting the Investors & Media section of the Cytokinetics ...

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 ...

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten is a next-in-class cardiac myosin inhibitor for the potential treatment of patients with HCM. In 2020, CORXEL (formerly Ji Xing) acquired the rig ...

Cytokinetics, Incorporated (CYTK) announced that the FDA has accepted the company’s new drug application (NDA) for lead pipeline candidate, aficamten.Aficamten is a next-in-class cardiac myosin inhibitor. The NDA is seeking approval of the candidate for the treatment of obstructive hypertrophic cardiomyopathy (HCM).Year to date, Cytokinetics’ shares have lost 39.5% compared with the industry’s 7% decline.Image Source: Zacks Investment ResearchCYTK’s NDA AcceptanceThe regulatory body assigned a standard revi ...

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment. Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of heart fa ...

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following December investor conferences: 7th Annual Evercore ISI HealthconX Conference: Cytokinetics will participate in a fireside chat on Tuesday, December 3, 2024 at 9:35 AM Eastern Time at the Loews Coral Gables Hotel in Coral Gables, FL.36th Annual Piper Sandler Healthcare Conference: Cytokinetics will participate in a fireside chat ...

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 Se ...