Myqorzo (aficamten)

New molecular entity

Region: 🇺🇸 US
Active substance: aficamten
Company: Cytokinetics
Status: Approved
FDA approval: Fri 19 Dec 2025
Designations: New molecular entity
Application: NDA219083
Official record: www.accessdata.fda.gov

Regulatory milestones

Sat 14 Nov 2026🇺🇸 PDUFA datecompany-announced

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

Thu 12 Feb 2026🇪🇺 EU approval (EC decision)

Myqorzo (aficamten) approved in the EU

Marketing authorisation to Cytokinetics (Ireland) Limited; Additional monitoring · source

Fri 19 Dec 2025🇺🇸 FDA approval

FDA approves Myqorzo (aficamten), a new medicine

Cytokinetics; NDA219083; New molecular entity; tablet · source

Thu 11 Dec 2025🇪🇺 CHMP positive opinion

Myqorzo (aficamten): CHMP positive opinion

Cytokinetics (Ireland) Limited; Additional monitoring · source

Same substance in other markets

🇪🇺 Myqorzo Authorised · Cytokinetics (Ireland) Limited

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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.