secwatch.observer — SEC 8-K summary
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Issuer:     Black Diamond Therapeutics, Inc. (BDTX)
CIK:        0001701541
Form:       8-K
Filed at:   2024-09-23T23:59:59+00:00
Accession:  0001104659-24-101874
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Black Diamond reports initial Phase 2 data for BDTX-1535 showing 42% ORR in recurrent EGFRm NSCLC
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- 200 mg daily dose selected for pivotal development; favorable tolerability with no new safety signals.
- Preliminary ORR of 42% (8/19) in patients with C797S or PACC osimertinib-resistance mutations; 14/19 remain on therapy.
- Duration of response ~8+ months for first 3 partial responders; mean follow-up 4.7 months.
- Regulatory feedback on registration path expected Q1 2025; initial first-line data expected Q1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701541/000110465924101874/0001104659-24-101874-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701541/000110465924101874/tm2424526d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-101874

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