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Cytokinetics (CYTK) investor relations material
Cytokinetics FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA Announcement summary19 Dec, 2025
Introduction and purpose
FDA approved Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (OHCM) in adults to improve functional capacity and symptoms.
The approval marks a significant milestone for patients with OHCM and the company, representing its first approved medicine.
The call included discussion of the approval, label, REMS, clinical data, commercial launch plans, and future outlook.
Details of approval or decision
Myqorzo is approved for adults with symptomatic OHCM, available in 5, 10, 15, and 20 mg tablets.
Approval is based on positive results from the pivotal Phase 3 SEQUOIA-HCM trial.
The label features a flexible dosing regimen, no requirement for drug-drug interaction monitoring, and a predictable safety profile.
Myqorzo is only available through a restricted REMS program due to heart failure risk, requiring prescriber and pharmacy certification, patient enrollment, and echo monitoring.
The only contraindication is with rifampin; no warnings for embryo-fetal toxicity or use with oral contraceptives.
Impact on industry and stakeholders
Myqorzo is expected to achieve over 50% preference share in the cardiac myosin inhibitor (CMI) category and expand the market.
The launch is supported by a comprehensive patient support program and experienced sales team.
The approval is anticipated to drive broader adoption among both Centers of Excellence and general cardiology practices.
Patient advocacy groups highlight the approval as a long-awaited advancement.
The company is preparing for global expansion, with approval in China and a positive opinion in the EU.
How will MYQORZO REMS affect market access?
Clarify MYQORZO DDI monitoring requirements?
What is the strategy for undiagnosed oHCM patients?
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Next Cytokinetics earnings date
Q4 202527 Feb, 2026
Next Cytokinetics earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Cytokinetics Inc is a biopharmaceutical company focused on developing small-molecule therapies aimed at muscle function. The company targets diseases associated with impaired cardiac and skeletal muscle performance, including heart failure and neuromuscular disorders. Its operations include clinical development and research. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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