Clinical EfficacyFirmonertinib demonstrated a high confirmed overall response rate at the higher-dose cohort, supporting meaningful efficacy in underserved EGFR-mutant lung cancer subtypes.
Commercial PreparednessAppointment of an experienced chief commercial officer signals active preparations for potential U.S. launch and broader commercialization efforts.
Regulatory PathwayGlobal Phase 3 head-to-head ALPACCA trial versus osimertinib/afatinib includes an interim analysis on response and progression that could enable accelerated approval, with topline data expected in early 2026.