Tag: Cytokinetics

Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil

Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval Company Expects to Request Meeting with FDA to Discuss Potential Next Steps Cytokinetics to Host Conference Call and Webcast on March 1, 2023 at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Feb. 28, […]

Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil

PDUFA Target Action Date is February 28, 2023 Cytokinetics to Host Conference Call and Webcast on December 14, 2022 at 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) Cardiovascular and Renal […]

Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-3828136

Advancement of Novel Cardiac Troponin Activator Expands Cardiovascular Franchise for Conditions Associated with Impaired Cardiac Contractility SOUTH SAN FRANCISCO, Calif., Dec. 07, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending […]

Cytokinetics Presents New Data at the American Heart Association Scientific Sessions 2022

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), as well as an analysis of patients hospitalized for heart failure with reduced ejection fraction (HFrEF) from the Get With The Guidelines®-Heart […]

Cytokinetics Reports Third Quarter 2022 Financial Results

Advisory Committee Meeting to Review NDA for Omecamtiv Mecarbil on December 13, 2022; PDUFA Target Action Date Set for February 28, 2023 SEQUOIA-HCM Continuing with Results Expected in 2H 2023; Patient Screening for Cohort 4 of REDWOOD-HCM Closed with Data Expected in 1H 2023 COURAGE-ALS Continuing Following First Interim Analysis, Enrollment Expected to Complete in […]