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Cytokinetics Reports Third Quarter 2021 Financial Results
Submission of NDA for Omecamtiv Mecarbil on Track to Occur in Q4 2021 Start-Up Activities Underway for SEQUOIA-HCM Enrollment Complete in Cohort 3 of
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Submission of NDA for Omecamtiv Mecarbil on Track to Occur in Q4 2021 Start-Up Activities Underway for SEQUOIA-HCM Enrollment Complete in Cohort 3 of REDWOOD-HCM; Results Expected in Q1 2022 SOUTH SAN FRANCISCO, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2021. Net loss for the third quarter was $76.1 million, or $0.95 per share, compared to net loss for the third quarter of 2020 of $3.2 million, or $0.05 per share. Cash, cash equivalents and investments totaled $668.9 million at September 30, 2021. “During the third quarter we were pleased to deliver against several key milestones across our late-stage pipeline, including our sharing positive results from REDWOOD-HCM and conducting start-up activities for SEQUOIA-HCM, our Phase 3 trial of aficamten. In parallel, we were pleased to start COURAGE-ALS, our Phase 3 trial of reldesemtiv while also advancing towards our goal of submitting the NDA for omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Moreover, after recently outlining our go-to-market strategy for omecamtiv mecarbil in the U.S., we are forging ahead to execute on those plans, supported by a strong and growing commercial organization with focus to building a cardiovascular franchise. All of this is occurring alongside an expansion of our research programs with the objective to support a sustainable pipeline of innovation.” Q3 and Recent Highlights Cardiac Muscle Programs omecamtiv mecarbil (cardiac myosin activator) Continued activities supportive of our plans to submit a New Drug Application (NDA) for omecamtiv mecarbil, which remains on track to occur in Q4 2021. Results from additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Denver, CO, showing that the effect of treatment with omecamtiv mecarbil in Black patients was consistent with the overall population and with white patients.Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect to complete METEO...