{"schema_version":"secwatch.filing_event.v1","accession":"0001725160-25-000013","form_type":"8-K","ticker":"ZNTL","cik":"0001725160","company_name":"Zentalis Pharmaceuticals, Inc.","filed_at":"2025-01-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.627061+00:00","generated_at":"2026-05-27T07:07:42.268451+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Zentalis reports azenosertib ORR 34.9% in Cyclin E1+ PROC; FDA aligned on DENALI Part 2 for accelerated approval path","bullets":["DENALI Part 1b in Cyclin E1+ PROC achieved 34.9% ORR (response-evaluable n=43) and ~5.5 months median DOR; ITT ORR 31.3%.","FDA aligned on seamless DENALI Part 2 design; enrollment to begin 1H 2025 with topline data by year-end 2026; potential accelerated approval.","MAMMOTH monotherapy in Cyclin E1+ patients at 400mg QD 5:2 showed 31.3% ORR (n=16); safety profile well-characterized with low discontinuation rate.","Company discontinues ZN-c3-016 (BRAF CRC expansion) due to resource prioritization; no further development of niraparib combination.","Corporate restructuring extended cash runway into late 2027, beyond expected DENALI Part 2 data readout."],"urls":{"canonical":"https://secwatch.observer/filing/0001725160-25-000013","json":"https://secwatch.observer/filing/0001725160-25-000013.json","markdown":"https://secwatch.observer/filing/0001725160-25-000013.md","text":"https://secwatch.observer/filing/0001725160-25-000013.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1725160/000172516025000013/0001725160-25-000013-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1725160/000172516025000013/zntl-20250129.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T07:07:42.268451+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"}