Cytokinetics Highlights Progress in Cardiac Myosin Modulation Programs and Global Commercial Launch Readiness at Investor & Analyst Day
NDA for Aficamten Submitted to FDA in Q3
COMET-HF, Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil, and AMBER-HFpEF, Phase 2 Clinical Trial of CK-586, Expected to Begin in Q4
Global Commercial Launch Preparations Underway for First Potential Approval Towards Building Specialty Cardiovascular Franchise
Company Recently Launched Unbranded Disease Awareness Campaign “HCM Beyond The Heart” for Health Care Professionals
SOUTH SAN FRANCISCO, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) will provide an update on the company’s cardiac myosin modulation programs and global commercial launch readiness for aficamten at its Investor and Analyst Day, “Heart Forward: Advancing Cardiac Myosin Modulation,” today at 8:30 AM Eastern Time in New York and streamed live online. The Company plans to synthesize recent updates from clinical trials relating to aficamten, a next-in-class cardiac myosin inhibitor, as well as share the design of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil, a cardiac myosin activator being developed for the potential treatment of patients with symptomatic heart failure (HF) and severely reduced ejection fraction, and the design of AMBER-HFpEF, a Phase 2 clinical trial of CK-4021586 (CK-586), another cardiac myosin inhibitor being developed for the potential treatment of patients with symptomatic heart failure with preserved ejection fraction (HFpEF) and hypercontractility. Today’s event will also feature perspectives from leading expert clinicians on the evolving landscape for the treatment of hypertrophic cardiomyopathy (HCM) and heart failure.
“Our pioneering science relating to the mechanics of cardiac muscle function continues to be the engine empowering Cytokinetics as we advance our specialty cardiology franchise focused on myosin modulation to address unmet patient needs in HCM as well as those patients with heart failure whose disease is characterized by irregularities in cardiac muscle contractility,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased to announce that we recently submitted the New Drug Application for aficamten to FDA, as we have continued to advance our later-stage development programs. As we approach the potential commercial launch of aficamten, we believe our bespoke commercial planning positions us well to deliver on our specialty cardiology franchise business objectives and, as bolstered by a strong balance sheet and available access to additional long-term capital, our corporate development strategies.”
COMET-HF: Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil
Today, Cytokinetics will present the design of COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a Phase 3 multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic HF with severely reduced ejection fraction.
Omecamtiv mecarbil was previously the subject of GALACTIC-HF, a Phase 3 clinical trial of omecamtiv mecarbil in over 8,000 patients with heart failure with reduced ejection fraction (HFrEF) which showed a statistically significant risk reduction of heart failure outcomes with omecamtiv mecarbil on top of standard of care. The magnitude of the treatment effect in the pre-specified subgroup of more than 4,000 patients with heart failure with severely reduced ejection fraction (
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