Black Diamond to Showcase Phase 2 Results of Silevertinib for Non-Small Cell Lung Cancer Today
Webcast Presentation: Black Diamond Therapeutics will host a webcast on December 3, 2025, to present results from its Phase 2 trial of silevertinib in non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations, including objective response rates and treatment duration data from 43 patients.
Clinical Trial Progress: Silevertinib is being evaluated in three clinical settings: first-line NSCLC, second/third-line NSCLC in C797S+ patients, and glioblastoma, with key data expected in the first half of 2026.
FDA Designation: The second/third-line NSCLC study has received FDA Fast Track designation, highlighting its potential to meet significant medical needs, while the company plans to seek FDA feedback on registration for the first-line NSCLC trial.
Financial Status: As of the end of Q3 2025, Black Diamond Therapeutics reported $135.5 million in cash and investments, projected to fund operations through Q4 2027, despite a recent stock price decline to $3.45.
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Black Diamond's Lung Cancer Treatment Demonstrates 60% Response Rate in Phase 2 Results
Phase 2 Trial Results: Black Diamond Therapeutics reported topline data from its Phase 2 trial of silevertinib in non-small cell lung cancer patients, showing a 60% objective response rate and 86% CNS response rate, with no new safety signals observed.
Stock Performance: Following the trial results, BDTX stock experienced a significant decline of 23.77%, trading at $2.62.
Future Plans: The company plans to present updated trial results in 2026 and is also set to initiate a randomized Phase 2 trial for glioblastoma patients in the first half of 2026.
Financial Outlook: Black Diamond has approximately $135.5 million in cash and investments, which it believes will cover operating expenses into the second half of 2028.
