Just two years from encouraging data to first FDA approval. After being awarded Fast-Track and Breakthrough Designation.
Quote:July 2023 (Interim Data): Initial data showed encouraging results in 42 patients (Cohort 1).
May 2024 (Phase Ia Data): Primary analysis of Phase Ia (data cut-off May 23, 2024) indicated an overall response rate (ORR) of 30% across tumor types, with promising activity in HER2-mutant NSCLC.
Nov 2024 (Phase Ib Data Cut-off): As of November 29, 2024, data showed a 71% confirmed objective response rate in pre-treated HER2-mutant NSCLC (Cohort 1).
Q3 2025 (FDA Approval - Prior Therapy): On August 8, 2025, the FDA granted accelerated approval based on Beamion LUNG-1 data.