Aficamten

Development notes

MAPLE-HCM trial (oHCM). Trial comparing aficamten to metoprolol. 5/13/25- Reported topline results, met primary endpoint. 8/30/25- Primary results presented at ESC'25. Present results from prespecified analysis at HFSA'25. 11/10/25- Additional analyses presented at AHA'25. 11/05/25:- MAPLE-HCM primary and supplemental analyses presented at ESC 2025 and HFSA 2025, reinforcing aficamten benefits and informing multiple recent peer-reviewed publications. 12/12/25:- FOREST-HCM open-label extension study in HCM patients noted; no new MAPLE-HCM data or timelines provided. 02/24/26:- sNDA for MAPLE-HCM submitted; FDA approval decision expected in Q4 2026. 03/16/26:- New MAPLE-HCM analyses (pooled, hypertension subset) to be presented at ACC March 28-30, 2026. 04/28/26:- MAPLE-HCM dose-response and sex-based analyses presented at ESC HF 2026 on May 10-11, 2026. 05/05/26:- sNDA for MAPLE-HCM accepted; FDA assigned PDUFA date November 14, 2026. 05/11/26:- ESC HF 2026 presented new MAPLE-HCM dose-response and sex analyses showing benefits versus metoprolol. 07/07/26:- MAPLE-HCM analyses to be presented at ESC Congress Aug 29, 2026. 08/06/26:- MAPLE-HCM analyses at ESC Heart Failure 2026 supported published oHCM data.