{"schema_version":"secwatch.filing_event.v1","accession":"0001655759-25-000098","form_type":"8-K","ticker":"ARVN","cik":"0001655759","company_name":"ARVINAS, INC.","filed_at":"2025-06-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.224176+00:00","generated_at":"2026-05-19T18:25:18.806751+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Arvinas submits NDA to FDA for vepdegestrant in ER+/HER2- ESR1-mutated breast cancer","bullets":["NDA supported by pivotal Phase 3 VERITAC-2 trial results presented at ASCO 2025 and published in NEJM.","Vepdegestrant is a first-in-class PROTAC ER degrader; fast track designation granted by FDA.","If approved, vepdegestrant would be first FDA-approved PROTAC ER degrader for advanced breast cancer.","Jointly developed with Pfizer (PFE); NDA covers ER+/HER2- ESR1-mutated advanced/metastatic breast cancer.","VERITAC-2 enrolled 624 patients across 25 countries; primary endpoint PFS in ESR1-mutation and ITT populations."],"urls":{"canonical":"https://secwatch.observer/filing/0001655759-25-000098","json":"https://secwatch.observer/filing/0001655759-25-000098.json","markdown":"https://secwatch.observer/filing/0001655759-25-000098.md","text":"https://secwatch.observer/filing/0001655759-25-000098.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1655759/000165575925000098/0001655759-25-000098-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1655759/000165575925000098/arvn-20250606.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T18:25:18.806751+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"}