Company Received Complete Response Letter from FDA for New Drug Application for Omecamtiv Mecarbil Data from Cohort 4 of REDWOOD-HCM to be Presented at the American College of Cardiology Scientific Sessions; Results Expected from SEQUOIA-HCM in Q4 2023 Second Interim Analysis of COURAGE-ALS Expected to Occur in Q2 2023 Company […]
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 Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
SOUTH SAN FRANCISCO, Calif., Feb. 01, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on January 31, 2023 it granted stock options to purchase an aggregate of 87,600 shares of common stock to 13 new employees, whose employment commenced in January 2023, as a material inducement to […]
Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
SOUTH SAN FRANCISCO, Calif., Jan. 04, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on December 30, 2022 it granted stock options to purchase an aggregate of 130,000 shares of common stock to 6 new employees, whose employment commenced in December 2022, as a material inducement to […]
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 Stock Trading Halted Today
FDA Advisory Committee to Review the New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company’s common stock. The […]
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 […]
Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
SOUTH SAN FRANCISCO, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on October 31, 2022 it granted stock options to purchase an aggregate of 202,500 shares of common stock to 20 new employees, whose employment commenced in October 2022, as a material inducement to […]