Business
Cytokinetics Reports First Quarter 2022 Financial Results
Initial Data from REDWOOD-HCM OLE, the Open Label Extension Study of Aficamten, to be Presented at Heart Failure 2022 on May 23, 2022 Continued Launch
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Initial Data from REDWOOD-HCM OLE, the Open Label Extension Study of Aficamten, to be Presented at Heart Failure 2022 on May 23, 2022 Continued Launch Readiness Activities and Buildout of Commercial Infrastructure in Advance of PDUFA Date of November 30, 2022 for Omecamtiv Mecarbil SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2022. Net loss for the first quarter was $89.4 million, or $1.05 per share, compared to net loss for the first quarter of 2021 of $47.1 million, or $0.66 per share. Cash, cash equivalents and investments totaled $686.1 million at March 31, 2022. “We achieved meaningful progress during the first quarter of 2022 with especially notable milestones relating to our cardiovascular pipeline, including the acceptance and filing of our NDA for omecamtiv mecarbil with FDA and the opening to enrollment in both SEQUOIA-HCM and Cohort 4 of REDWOOD-HCM. Additionally we shared positive data from Cohort 3 of REDWOOD-HCM demonstrating a substantial treatment effect with aficamten in patients taking disopyramide, and additional data from GALACTIC-HF reinforcing its safety, ease of initiation in the hospital setting and potential to reduce costs associated with fewer hospitalizations,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Having secured long-term capital from Royalty Pharma also in the first quarter, our stronger balance sheet enables us to both accelerate our development of aficamten as well as to advance commercial readiness activities supportive of the potential approval of omecamtiv mecarbil this year.” Q1 and Recent Highlights Cardiac Muscle Programs omecamtiv mecarbil (cardiac myosin activator) The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.Continued building our commercial infrastructure and launch readiness capabilities for omecamtiv mecarbil in the U.S. including initiation of hiring first line field-based sales force leaders, selection of a patient services partner, and activities related to field force ope...