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Cytokinetics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
GlobeNewswire News Room· 2025-01-06 21:00
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 ...
Cytokinetics Announces European Medicines Agency Validation of Marketing Authorization Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Newsfilter· 2024-12-23 12:30
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 ...
Cytokinetics Announces Sanofi Acquired Rights to Develop and Commercialize Aficamten in Greater China
Newsfilter· 2024-12-20 05:00
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 ...
FDA Accepts Cytokinetics' Application for Cardiovascular Drug
ZACKS· 2024-12-03 19:40
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 ...
Cytokinetics Announces Start of COMET-HF, a Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction
GlobeNewswire News Room· 2024-12-03 12:30
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 ...
Cytokinetics to Participate in December Investor Conferences
GlobeNewswire News Room· 2024-12-02 21:00
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 ...
Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
GlobeNewswire News Room· 2024-12-02 12:30
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 ...
Cytokinetics and Bayer Announce Exclusive Licensing Collaboration for Aficamten in Japan
GlobeNewswire News Room· 2024-11-19 07:30
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 ...
Cytokinetics Presents Additional Data From GALACTIC-HF at the American Heart Association Scientific Sessions 2024
GlobeNewswire News Room· 2024-11-16 14:00
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 ...
Cytokinetics Presents New Data Relating to Aficamten and Hypertrophic Cardiomyopathy at the American Heart Association Scientific Sessions 2024
GlobeNewswire News Room· 2024-11-16 14:00
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 ...