IGALMI (dexmedetomidine) — Regulatory decision
Late 2026
sNDA submission timeline supports potential approval as early as year-end 2026Source filing
BTAI biotech catalysts & pipeline
BIOXCEL THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
IGALMI ® (dexmedetomidine) — PDUFA
Nov 14
The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of November 14, 2026.Source filing