---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-117975"
form_type: "8-K"
ticker: "BDTX"
cik: "0001701541"
company_name: "Black Diamond Therapeutics, Inc."
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:16:16.608134+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Black Diamond reports 60% ORR for silevertinib in 1L NSCLC; plans Phase 2 GBM trial; cash into 2H 2028

## Summary
- 60% ORR (26/43) in 1L NSCLC with 35 distinct non-classical EGFR mutations; 86% CNS ORR in patients with brain metastases.
- No new safety signals; AEs managed with supportive care; 29/43 patients remain on therapy, longest >19 months.
- Plans randomized Phase 2 trial of silevertinib+TMZ in ~150 ND GBM patients, initiated 1H 2026, preliminary data expected 2028.
- Cash $135.5M as of Sep 30, 2025, now expected to fund operations into 2H 2028; partner assumed for NSCLC pivotal.
- PFS and DOR data for NSCLC (recurrent and frontline) expected at medical meeting in Q2 2026.

## SEC filing metadata
- accession: 0001104659-25-117975
- form_type: 8-K
- ticker: BDTX
- cik: 0001701541
- company_name: Black Diamond Therapeutics, Inc.
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701541/000110465925117975/0001104659-25-117975-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701541/000110465925117975/tm2532577d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-117975
- JSON: https://secwatch.observer/filing/0001104659-25-117975.json
- Plain text: https://secwatch.observer/filing/0001104659-25-117975.txt

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