CYTOKINETICS INC 8-K
Research Summary
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Cytokinetics Inc. Announces EU Approval of MYQORZO (aficamten)
What Happened Cytokinetics, Incorporated filed a Form 8-K on February 17, 2026, announcing that the European Commission has approved MYQORZO® (aficamten) tablets for the treatment of symptomatic (NYHA class II–III) obstructive hypertrophic cardiomyopathy in adult patients. The approved tablet strengths are 5 mg, 10 mg, 15 mg and 20 mg. The company describes MYQORZO (aficamten) as an allosteric, reversible inhibitor of cardiac myosin motor activity.
Key Details
- Filing date: Form 8-K filed February 17, 2026, reporting the announcement.
- Approved product: MYQORZO® (aficamten) — 5 mg, 10 mg, 15 mg, 20 mg tablets.
- Indication: Symptomatic (NYHA class II–III) obstructive hypertrophic cardiomyopathy in adults.
- Mechanism: Allosteric and reversible inhibitor of cardiac myosin motor activity.
Why It Matters This is a regulatory milestone for Cytokinetics: European Commission approval allows the company (and/or its commercial partners) to seek marketing, reimbursement and launch activities for MYQORZO in the EU for the approved indication. The 8-K announces the approval but does not provide financial guidance, sales forecasts, or launch timing; those items will be important next updates for investors assessing potential revenue impact.