Filing Analysis
Black Diamond Therapeutics announced positive Phase 2 clinical trial results for its drug candidate, silevertinib, in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations. The trial demonstrated a preliminary median progression-free survival of 15.2 months and a 60% objective response rate, supporting advancement to pivotal development.
📋 Key Facts
- Enrolled 43 frontline NSCLC patients with EGFR non-classical mutations, including 19 with brain metastases.
- Preliminary median progression-free survival (PFS) is 15.2 months, and median duration of response (DOR) has not yet been reached.
- The overall Objective Response Rate (ORR) was 60%, and the Disease Control Rate (DCR) was 91%.
- CNS Objective Response Rate (ORR) was 86% among patients with measurable central nervous system lesions.
- Safety and efficacy data support a 150 mg QD dose for pivotal development, with Grade 3 or higher treatment-related adverse events reduced to 28% following dose reduction.
Black Diamond Therapeutics, Inc. (BDTX) reported its financial results for the first quarter ended March 31, 2026. The disclosure was made via a press release furnished as an exhibit to the 8-K filing.
📋 Key Facts
- The filing reports financial results for the three months ended March 31, 2026.
- The report was filed on May 7, 2026, which is also the date of the earliest event reported.
- The information was furnished under Item 2.02 (Results of Operations and Financial Condition).
- Exhibit 99.1 contains the full press release with the financial announcement.
Black Diamond Therapeutics announced its financial results for the fourth quarter and full year ended December 31, 2025. The disclosure was made through a press release furnished as an exhibit to the filing.
📋 Key Facts
- Financial results reported for the fiscal year ended December 31, 2025.
- Financial results reported for the three months ended December 31, 2025.
- The filing was made under Item 2.02 (Results of Operations and Financial Condition).
- The report was signed by Brent Hatzis-Schoch, COO and General Counsel.