secwatch.observer — SEC 8-K summary
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Issuer:     Black Diamond Therapeutics, Inc. (BDTX)
CIK:        0001701541
Form:       8-K
Filed at:   2026-05-21T21:19:10+00:00
Accession:  0001104659-26-065254
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Black Diamond reports positive Phase 2 silevertinib results; mPFS 15.2 months in EGFR-NCM NSCLC
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- Preliminary mPFS 15.2 months (95% CI: 10.8, NE); median DOR not reached; 53% of patients remain on therapy.
- CNS ORR 86%; no de novo brain metastases observed; 19 patients with brain metastases at baseline.
- ORR 60%, DCR 91%; VAF reduction in all evaluable patients across 25 unique EGFR-NCMs including PACC.
- No new safety signals; TRAEs > Grade 3 reduced to 28% after dose reduction; 150 mg QD selected for pivotal development.
- Company plans to meet with FDA later this year to discuss pivotal development plan.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701541/000110465926065254/0001104659-26-065254-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701541/000110465926065254/tm2615293d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-065254

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer