secwatch.observer — SEC 8-K summary
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Issuer:     Black Diamond Therapeutics, Inc. (BDTX)
CIK:        0001701541
Form:       8-K
Filed at:   2023-12-13T23:59:59+00:00
Accession:  0001104659-23-125566
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Black Diamond reports Phase 1 topline data for BDTX-1535 in recurrent GBM; durable stabilization seen
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- 22 evaluable patients: 3 on therapy >10 months, 1 >6 months, 5 >4 months; historical PFS is 2–4 months.
- 19 measurable disease patients: 1 confirmed partial response (200 mg QD) and 8 stable disease per RANO criteria.
- No new safety signals; AEs were Grade 1–2 diarrhea and rash, consistent with EGFR TKI class.
- One patient remains on 100 mg QD for >15 months after progression on temozolomide at 3 months.
- Company plans to present dose escalation results at a medical meeting in Q2 2024; window-of-opportunity trial enrolling.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701541/000110465923125566/0001104659-23-125566-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701541/000110465923125566/tm2332757d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-125566

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