Company Overview - Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing drug candidates that target muscle biology for treating diseases with compromised cardiac muscle performance [3] - The company is developing several drug candidates, including aficamten, a cardiac myosin inhibitor, and omecamtiv mecarbil, a cardiac myosin activator, aimed at treating various forms of heart failure [3] Upcoming Events - Robert I. Blum, President and CEO of Cytokinetics, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 9:00 AM Pacific Time [1] - Interested parties can access the live webcast of the presentation on the Cytokinetics website, with a replay available for 90 days post-event [2] Product Development - Aficamten is being prepared for potential commercialization following positive results from the SEQUOIA-HCM Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy [3] - The company is also evaluating aficamten in additional clinical trials for both obstructive and non-obstructive hypertrophic cardiomyopathy [3] - Other drug candidates include CK-586, targeting heart failure with preserved ejection fraction, and CK-089, aimed at specific muscular dystrophies and impaired skeletal muscle function [3]

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 ...

Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics Up to €490 Million in Commercial Milestone Payments, withTiered Royalties on Future Sales SOUTH SAN FRANCISCO, Calif. and BERLIN, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) and Bayer today announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive hy ...

Two New Analyses from SEQUOIA-HCM Demonstrate Treatment with Aficamten Improves Post-Exercise Oxygen Uptake Recovery and Quality of Life New Data from FOREST-HCM Demonstrate Aficamten Durably Reduces the Proportion of Patients Guideline Eligible for Septal Reduction Therapy Analyses of Real-World Data Reveal Cost of Care Differences in HCM Across Gender, Age and Race/Ethnicity SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data re ...

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL. “These analyses reinforce the potential treatment benefit of omecamtiv mecar ...