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 propel Cytokinetics to becoming the leading muscle-focused specialty biopharmaceutical company intent on meaningfully improving the lives of patients through global access to innovative medicines.
“In 2025 we are poised for a defining year with principal focus to the potential approval and commercial launch of aficamten for obstructive HCM in the United States. At the same time, we are executing on a robust clinical trials development program for aficamten inclusive of MAPLE-HCM, with results expected in the first half of this year as may potentially support the use of aficamten as monotherapy,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In addition, we are advancing our later-stage development programs for omecamtiv mecarbil and CK-586 in adjacent specialty cardiology indications with intention to further augment our pipeline over time. Cytokinetics is well positioned to prudently and meaningfully deliver increased shareholder value as we continue to execute well on key milestones and position the company to achieve longer-term aspirations defining of our Vision 2030.”
Expected 2025 Milestones
Cardiac Muscle Programs
Aficamten (cardiac myosin inhibitor)
Advance go-to-market strategies and prepare to commercially launch aficamten in the U.S. in 2H 2025, subject to approval by the U.S. Food & Drug Administration (FDA).
Continue go-to-market plans in Germany and expand commercial readiness activities in Europe in 2025, in preparation for potential approval by the European Medicines Agency (EMA) in 1H 2026.
Coordinate with Sanofi to support the potential approval of aficamten in China in 2H 2025, pending approval by the National Medical Products Administration (NMPA).
Report topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), the Phase 3 clinical trial comparing aficamten as monotherapy to metoprolol as monotherapy in patients with symptomatic obstructive HCM, in 1H 2025.
Complete patient enrollment of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, in 2H 2025.
Complete enrollment of the adolescent cohort in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM, in 2H 2025.
Omecamtiv mecarbil (cardiac myosin activator)
Continue patient enrollment in COMET-HF (Confirmation of Omecamtiv MecarbilEfficacy Trial in Heart Failure), a confirmatory Phase 3 clinical of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF) through 2025 to enable completion of enrollment in 2026.
CK-586 (cardiac myosin inhibitor)
Complete enrollment of the first two patient cohorts in AMBER-HFpEF, (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of CK-586 in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) in 2H 2025.
Skeletal Muscle Program
CK-089 (fast skeletal muscle troponin activator)
Complete the Phase 1 study of CK-089 in healthy human participants in 2025.
Ongoing Research
Continue ongoing pre-clinical development and research activities directed to additional muscle biology focused programs.
Vision 2030
The Company also outlined its Vision 2030: “Empowering Muscle, Empowering Lives” with the following objectives:
Innovation: Advance two approved products across three indications and ten novel molecular entities (NMEs) in our pipeline.
Ignition: Achieve broad access and rapid use of our medicines in >15 countries throughout North America and Europe.
Impact: Reach >100,000 patients globally with our medicines.
Inspiration: Foster a patient-centric culture with emphasis on equitable access.
“Our Vision 2030 provides the aspirational roadmap, aligned with our corporate five-year strategic plan, that will propel us forward as a fully integrated and leading specialty biopharma company intent on delivering innovative medicines to patients around the world,” said Mr. Blum. “Vision 2030 articulates ambitious company goals to deliver product approvals, achieve broad access to our medicines, promote equitable access and advance our pioneering research to benefit patients, shareholders and employees.”
About Cytokinetics
Cytokinetics is a late-stage, muscle biology specialty biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, Cytokinetics is intent on meaningfully improving the lives of patients through global access to innovative medicines. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a next-in-class cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements express or implied relating to the properties or potential benefits of aficamten or any of our other drug candidates, our ability to obtain regulatory approval for aficamten for the treatment of obstructive hypertrophic cardiomyopathy or any other indication from FDA or any other regulatory body in the United States or abroad on a timely basis, or at all, the labeling or post-marketing conditions that FDA or another regulatory body may require in connection with the approval of aficamten, our ability to timely enroll and complete the ACACIA-HCM, AMBER-HFpEF, CEDAR-HCM, COMET-HF or CK-089 clinical trials, our ability to timely report the results of the MAPLE-HCM trial, and our ability achieve any element of our Vision 2030. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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