Cytokinetics
3 products tracked · names used in filings: Cytokinetics, Cytokinetics Inc, Cytokinetics (Ireland) Limited
Upcoming milestones
MYQORZO: PDUFA target action date (symptomatic obstructive HCM (based on MAPLE-HCM, vs. metoprolol))
Cytokinetics Inc (CYTK); aficamten; sNDA; status: set; "…F: heart failure with preserved ejection fraction; HFrEF: heart failure with reserved ejection fraction 5 Positioned for Launch & Sustainable Growth COMMERCIAL RESEARCH & DEVELOPMENT STRONG FINANCIAL POSITION Specialty Muscle-directed platform Cardiology ~$1.1B with multi-program pipeline Franchise cash, cash…"; filed 2026-05-05 · source
Recent milestones
Myqorzo (aficamten) approved in the EU
Marketing authorisation to Cytokinetics (Ireland) Limited; Additional monitoring · source
aficamten: PDUFA target action date (obstructive hypertrophic cardiomyopathy (HCM))
Cytokinetics Inc (CYTK); aficamten; NDA; status: set; "CYTOKINETICS REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Interactions with FDA Progressing Towards December 26, 2025 PDUFA Date for Aficamten; U.S."; filed 2025-11-05 · source
FDA approves Myqorzo (aficamten), a new medicine
Cytokinetics; NDA219083; New molecular entity; tablet · source
Myqorzo (aficamten): CHMP positive opinion
Cytokinetics (Ireland) Limited; Additional monitoring · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Kinharto omecamtiv mecarbil | Application withdrawn | |
| 🇪🇺 | Myqorzo aficamten | Authorised | 2026-02-12 |
| 🇺🇸 | Myqorzo aficamten | Approved | 2025-12-19 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.