Shares of Cytokinetics (CYTK) gained 2.2% on Wednesday after the company began enrolling patients in its mid-stage study of CK-4021586 (CK-586), a cardiac myosin inhibitor, for treating heart failure patients. The intended patient population includes those with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥60%.   The primary goal of the phase II AMBER-HFpEF study is to evaluate the safety and tolerability profile of CK-586 compared to plac ...

Stifel initiated coverage on Cytokinetics Incorporated CYTK, noting the company’s catalyst rich one to two years.The M&A speculation ramped up in early 2024 after the company released SEQUOIA-HCM Phase 3 trial data of aficamten in December 2023. However, last year, Novartis AG NVS decided to step back from pursuing the Cytokinetics deal.Amgen Inc AMGN, AstraZeneca Plc AZN, and Johnson & Johnson JNJ also all popped up as potential suitors, though the stock faded from there as a deal never materialized.Also R ...

SOUTH SAN FRANCISCO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment. AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial of CK-4021586 (CK-586) in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejec ...

Core Insights - Cytokinetics, Inc. is preparing for the potential approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S. by September 26, 2025, with significant milestones planned for 2025 [1][3][4] - The company has outlined its Vision 2030, aiming to become a leading muscle-focused specialty biopharmaceutical company, with strategic objectives to enhance patient access to innovative medicines [2][10] 2025 Milestones - Aficamten is expected to be commercially launched in the U.S. in the second half of 2025, pending FDA approval [7] - The company plans to continue patient enrollment in the COMET-HF trial for omecamtiv mecarbil through 2025, with completion expected in 2026 [4] - Enrollment for the AMBER-HFpEF trial of CK-586 is set to be completed in the second half of 2025 [5] Clinical Trials and Development - The MAPLE-HCM trial results, comparing aficamten to metoprolol, are anticipated in the first half of 2025 [7] - The ACACIA-HCM trial for aficamten in non-obstructive HCM is expected to complete enrollment in the second half of 2025 [7] - The CEDAR-HCM trial for pediatric patients is also set to complete enrollment in the second half of 2025 [7] Vision 2030 Objectives - The Vision 2030 roadmap includes goals to deliver product approvals, achieve broad access to medicines, and promote equitable access [10][14] - The company aims to reach over 100,000 patients globally with its medicines and extend its leadership in muscle biology through multiple therapeutic modalities [14]

PDUFA Target Action Date for Aficamten Set for September 26, 2025;Commercial Launch Preparations Underway for First Potential Approval Five-Year Aspirations Outline Corporate Strategies to Becoming Leading Muscle Biology Specialty Biopharma Company SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) today provided guidance for corporate milestones expected to occur in 2025 and outlined its aspirational Vision 2030, five-year strategic objectives designed to prope ...

Company Overview - Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing drug candidates that target muscle biology for treating diseases with compromised cardiac muscle performance [3] - The company is developing several drug candidates, including aficamten, a cardiac myosin inhibitor, and omecamtiv mecarbil, a cardiac myosin activator, aimed at treating various forms of heart failure [3] Upcoming Events - Robert I. Blum, President and CEO of Cytokinetics, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 9:00 AM Pacific Time [1] - Interested parties can access the live webcast of the presentation on the Cytokinetics website, with a replay available for 90 days post-event [2] Product Development - Aficamten is being prepared for potential commercialization following positive results from the SEQUOIA-HCM Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy [3] - The company is also evaluating aficamten in additional clinical trials for both obstructive and non-obstructive hypertrophic cardiomyopathy [3] - Other drug candidates include CK-586, targeting heart failure with preserved ejection fraction, and CK-089, aimed at specific muscular dystrophies and impaired skeletal muscle function [3]

SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). "With regulatory filings for aficamten already under review in both the U.S ...

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten is a next-in-class cardiac myosin inhibitor for the potential treatment of patients with HCM. In 2020, CORXEL (formerly Ji Xing) acquired the rig ...

Cytokinetics, Incorporated (CYTK) announced that the FDA has accepted the company’s new drug application (NDA) for lead pipeline candidate, aficamten.Aficamten is a next-in-class cardiac myosin inhibitor. The NDA is seeking approval of the candidate for the treatment of obstructive hypertrophic cardiomyopathy (HCM).Year to date, Cytokinetics’ shares have lost 39.5% compared with the industry’s 7% decline.Image Source: Zacks Investment ResearchCYTK’s NDA AcceptanceThe regulatory body assigned a standard revi ...

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment. Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of heart fa ...