Aficamten: MAPLE-HCM supplemental FDA decision
The FDA accepted the MAPLE-HCM supplemental application for aficamten, with a November 14, 2026 target. This concerns an additional label supported by MAPLE-HCM, not initial approval of MYQORZO and not the separate ACACIA-HCM non-obstructive program.
What matters
Follow the exact application, indication and requested label. An FDA decision concerns the drug program, while the company’s stock also reflects its other assets and business.
Primary evidence
FDA target 2026-11-14 — not a guaranteed decision date
Potential outcome market
Will FDA approve aficamten for the MAPLE-HCM supplemental label application in obstructive hypertrophic cardiomyopathy by a separately fixed evidence cutoff?
This event is research, not a listed market. A market needs a precise question, resolution rules and liquidity before trading opens.