Black Diamond Therapeutics (BDTX) experienced a sharp 35.8% decline in shares following a mixed market response to the Phase II update of its lead candidate, silevertinib, for first-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations. The study, which included 43 patients, reported a preliminary median progression-free survival (mPFS) of 15.2 months and an objective response rate of 60%, yet raised concerns over the small sample size and dosing safety management.
The Phase II study’s findings were based on a data cutoff date of April 11, 2026. Notably, 53% of patients remained on therapy, with no new safety signals, although severe treatment-related adverse events decreased to 28% after dose adjustments. Black Diamond is poised to meet with the FDA later in 2026 to discuss further development plans for silevertinib.
Year-to-date, BDTX shares have declined 6.2%, reinforcing investor apprehension about the clinical data’s early stage and the need for more comprehensive results. The company is not only focused on NSCLC but is also expanding its research into glioblastoma, recently initiating a Phase II study for EGFRvIII-positive GBM.
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