Myqorzo (aficamten)
- Region
- 🇪🇺 EU
- Active substance
- aficamten
- Company
- Cytokinetics (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Cardiomyopathy, Hypertrophic
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Thu 12 Feb 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006228
- Official record
- www.ema.europa.eu
Indication
Myqorzo is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
Regulatory 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
Myqorzo (aficamten) approved in the EU
Marketing authorisation to Cytokinetics (Ireland) Limited; Additional monitoring · 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
Same substance in other markets
- 🇺🇸 Myqorzo Approved · Cytokinetics
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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.