secwatch.observer — SEC 8-K summary
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Issuer:     Black Diamond Therapeutics, Inc. (BDTX)
CIK:        0001701541
Form:       8-K
Filed at:   2023-06-27T23:59:59+00:00
Accession:  0001104659-23-074995
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BDTX-1535 shows 5/12 NSCLC patients with confirmed partial response; expansion cohorts planned
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- 5 of 12 evaluable NSCLC patients achieved confirmed partial response per RECIST 1.1; 1 unconfirmed PR, 6 stable disease.
- No dose-limiting toxicity at 15-200 mg QD; DLTs observed at 300 mg (1/15) and 400 mg (5/12).
- Enrollment to start at 200 mg QD in two NSCLC expansion cohorts targeting acquired resistance and intrinsic driver mutations.
- FDA meeting planned in H2 2023 to discuss dosing strategy and potential accelerated approval path.
- Phase 1 GBM dose escalation update expected in Q4 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701541/000110465923074995/0001104659-23-074995-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701541/000110465923074995/tm2319750d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-074995

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