{"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","discovered_at":"2026-05-14T18:02:40.186321+00:00","generated_at":"2026-05-16T15:16:16.608134+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Black Diamond reports 60% ORR for silevertinib in 1L NSCLC; plans Phase 2 GBM trial; cash into 2H 2028","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-117975","json":"https://secwatch.observer/filing/0001104659-25-117975.json","markdown":"https://secwatch.observer/filing/0001104659-25-117975.md","text":"https://secwatch.observer/filing/0001104659-25-117975.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:16:16.608134+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}