Business
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
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"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 1H 2023 SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2022. Net loss for the third quarter was $142.3 million, or $1.52 per share, compared to net loss for the third quarter of 2021 of $76.1 million, or $0.95 per share. Cash, cash equivalents and investments totaled $896.2 million at September 30, 2022. “During the third quarter, we continued to execute towards our potential transformation to commercialization with expansion of teams and readiness activities in preparation for our upcoming FDA Advisory Committee meeting and the potential launch of omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “At the same time, the development program for aficamten is proceeding with continued conduct of Cohort 4 of REDWOOD-HCM and SEQUOIA-HCM, alongside start up activities for our second Phase 3 clinical trial of aficamten. We also are continuing COURAGE-ALS following its first interim analysis marking progress aligned with our commitment to ALS. We have entered the fourth quarter with a strong balance sheet ahead of key corporate milestones.” Q3 and Recent Highlights Cardiac Muscle Programs omecamtiv mecarbil (cardiac myosin activator) Engaged in further interactions with the U.S. Food and Drug Administration (FDA) related to our New Drug Application (NDA) for omecamtiv mecarbil. Continued discussions with FDA regarding matters related to substantial evidence of efficacy, benefit-risk, and dosing.Conducted meetings with assigned rapporteurs to discuss the planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).Continued commercial preparations for the potential U.S. launch of omecamtiv mecarbil including convening meetings with national and regional payers, advancing wholesaler agreements for distribution, finalizing third party logistics agreement, completing strategic sourci...