{"schema_version":"secwatch.filing_event.v1","accession":"0001655759-25-000095","form_type":"8-K","ticker":"ARVN","cik":"0001655759","company_name":"ARVINAS, INC.","filed_at":"2025-06-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.223923+00:00","generated_at":"2026-05-20T02:58:58.270678+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Arvinas/Pfizer vepdegestrant VERITAC-2: PFS benefit in ESR1m patients; NDA in H2 2025","bullets":["In ESR1m patients, vepdegestrant reduced progression/death risk by 43% (HR=0.57); median PFS 5.0 vs 2.1 months (p<0.001).","ITT population median PFS 3.7 vs 3.6 months (HR=0.83, p=0.07), not statistically significant.","Secondary endpoints in ESR1m: ORR 18.6% vs 4.0% (OR 5.45), CBR 42.1% vs 20.2% (OR 2.88).","Safety profile generally well tolerated; GI events low (nausea 13.5%); discontinuation 2.9% vs 0.7%.","Companies plan to submit NDA to FDA in H2 2025; OS data immature at analysis."],"urls":{"canonical":"https://secwatch.observer/filing/0001655759-25-000095","json":"https://secwatch.observer/filing/0001655759-25-000095.json","markdown":"https://secwatch.observer/filing/0001655759-25-000095.md","text":"https://secwatch.observer/filing/0001655759-25-000095.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1655759/000165575925000095/0001655759-25-000095-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1655759/000165575925000095/arvn-20250531.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T02:58:58.270678+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"}