secwatch / observer

8-K filed May 21, 2026, 5:19 PM ET ticker BDTX CIK 0001701541

other material confidence high sentiment positive materiality 0.80

Black Diamond reports positive Phase 2 silevertinib results; mPFS 15.2 months in EGFR-NCM NSCLC

Black Diamond Therapeutics, Inc.

Preliminary mPFS 15.2 months (95% CI: 10.8, NE); median DOR not reached; 53% of patients remain on therapy.
CNS ORR 86%; no de novo brain metastases observed; 19 patients with brain metastases at baseline.
ORR 60%, DCR 91%; VAF reduction in all evaluable patients across 25 unique EGFR-NCMs including PACC.
No new safety signals; TRAEs > Grade 3 reduced to 28% after dose reduction; 150 mg QD selected for pivotal development.
Company plans to meet with FDA later this year to discuss pivotal development plan.

item 7.01 item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001104659-26-065254
form_type: 8-K
ticker: BDTX
cik: 0001701541
company_name: Black Diamond Therapeutics, Inc.
filed_at: 2026-05-21T21:19:10+00:00
discovered_at: 2026-05-21T21:20:00.191691+00:00
generated_at: 2026-05-21T21:23:54.207839+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.8
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confidence: high
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text_url: https://secwatch.observer/filing/0001104659-26-065254.txt
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