MYQORZO (aficamten)
Obstructive hypertrophic cardiomyopathy · Adults with symptomatic obstructive hypertrophic cardiomyopathy; supplemental application supported by MAPLE-HCM comparing aficamten monotherapy with metoprolol monotherapy
CYTK · Cytokinetics
Full timeline
5 milestonesFDA decision expected
FDA assigned a November 14, 2026 PDUFA date to the MAPLE-HCM supplemental application.
Cytokinetics — sNDA acceptance and PDUFA date↗FDA acceptance of the sNDA was reported
Cytokinetics reported that FDA accepted the supplemental application supported by the Phase 3 MAPLE-HCM study.
Cytokinetics — MAPLE-HCM sNDA acceptance↗Cytokinetics reported submitting the sNDA
The company submitted the supplemental application following the initial U.S. approval and launch of MYQORZO for symptomatic obstructive HCM.
Cytokinetics — Fourth-quarter 2025 results and sNDA submission↗MAPLE-HCM results were presented and published
Aficamten was superior to metoprolol for change in peak oxygen uptake and five of six secondary endpoints in the Phase 3 active-comparator study.
Cytokinetics — Primary MAPLE-HCM results↗Related News
Cytokinetics to Participate in November Investor Conferences
Nov 2, 2026Cytokinetics Announces Three Upcoming Presentations at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions Held in Collaboration with the American Heart Association Scientific Sessions 2026
Oct 21, 2026Cytokinetics to Announce Third Quarter Results on November 4, 2026
Oct 19, 2026Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Oct 19, 2026Cytokinetics Announces Health Canada Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy