---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-101874"
form_type: "8-K"
ticker: "BDTX"
cik: "0001701541"
company_name: "Black Diamond Therapeutics, Inc."
filed_at: "2024-09-23T23:59:59+00:00"
generated_at: "2026-05-31T02:27:34.585446+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Black Diamond reports initial Phase 2 data for BDTX-1535 showing 42% ORR in recurrent EGFRm NSCLC

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-101874
- form_type: 8-K
- ticker: BDTX
- cik: 0001701541
- company_name: Black Diamond Therapeutics, Inc.
- filed_at: 2024-09-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701541/000110465924101874/0001104659-24-101874-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701541/000110465924101874/tm2424526d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-101874
- JSON: https://secwatch.observer/filing/0001104659-24-101874.json
- Plain text: https://secwatch.observer/filing/0001104659-24-101874.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.