silevertinib — FDA meeting
2026
We look forward to meeting with the FDA later this year to discuss our pivotal development plan.Source filing
BDTX biotech catalysts & pipeline
BLACK DIAMOND THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
silevertinib — Interim data
Q4 2026
The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.Source filing
silevertinib — Regulatory decision
Q4 2026
The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026.Source filing
silevertinib — Interim data
H1 2028
The primary endpoint of the trial will be PFS (RANO by blinded independent committee review, or BICR), with a planned futility analysis, and an interim PFS analysis anticipated in the first half of 2028.Source filing
silevertinib — Initial data
2028
Based on encouraging CNS activity of silevertinib in multiple trials across NSCLC and GBM, Company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in 1H 2026; initial data anticipated in 2028Source filing