FDA Plans to Convene Advisory Committee Meeting SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food & Drug Administration (FDA) and was informed that the Agency plans to convene an […]
Tag: Cytokinetics
Cytokinetics Announces Results From METEORIC-HF and Additional Data From GALACTIC-HF Presented at the American College of Cardiology 71st Annual Scientific Session
No Effect of Omecamtiv Mecarbil On Exercise Capacity in Patients with Heart Failure with Reduced Ejection Fraction in METEORIC-HF Healthcare Resource Utilization and Cost Analysis from GALACTIC-HF Demonstrate Treatment with Omecamtiv Mecarbil Led to 19% Cost Reduction Per Patient in Key Subgroup Additional Results from GALACTIC-HF Indicate Treatment with Omecamtiv […]
Cytokinetics Announces Cohort 4 of REDWOOD-HCM Is Open to Enrollment
Cohort 4 to Enroll Patients with Non-Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the opening of enrollment in Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), an ongoing Phase 2 clinical trial of aficamten, an investigational next-generation cardiac […]
Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)
SOUTH SAN FRANCISCO, Calif., March 01, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on February 28, 2022 it granted stock options to purchase an aggregate of 86,850 shares of common stock to eight new employees, whose employment commenced in February 2022, as a material inducement to […]
Cytokinetics Reports Fourth Quarter 2021 Financial Results
Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of November 30, 2022 SEQUOIA-HCM Open to Enrollment; Development Program for Aficamten Expanding in 2022 Company Provides 2022 Financial Guidance; More Than 2 Years of Cash Runway SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) — Cytokinetics, […]
Cytokinetics Announces Start of SEQUOIA-HCM, a Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Pivotal Trial to Assess the Potential of Aficamten to Improve Exercise Capacity, Heart Failure Symptoms and Functional Class SOUTH SAN FRANCISCO, Calif., Feb. 23, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic obstructive […]
Cytokinetics and the American Heart Association Bay Area Announce a Three-Year Collaboration to Advance Education and Awareness of Heart Disease
SOUTH SAN FRANCISCO, Calif. and OAKLAND, Calif., Feb. 16, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) and the American Heart Association (AHA) Bay Area today announced a three-year collaboration to accelerate education and awareness of heart disease. Within the collaboration, Cytokinetics will provide funding and support for several initiatives […]
Cytokinetics Announces Topline Results From METEORIC-HF
No Effect of Omecamtiv Mecarbil On Exercise Capacity in Patients with Heart Failure with Reduced Ejection Fraction Results Will Be Presented in Late Breaking Clinical Trial Session at the American College of Cardiology 71st Annual Scientific Session & Expo NDA for Omecamtiv Mecarbil Recently Accepted for Review by FDA Based on Results of […]
Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction
PDUFA Target Action Date Set for November 30, 2022 FDA is Currently Not Planning to Hold an Advisory Committee Meeting to Discuss the Application SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted and […]
Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on January 31, 2022 it granted stock options to purchase an aggregate of 200,700 shares of common stock to 15 new employees, whose employment commenced in January 2022, as a material inducement to […]
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