{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-064919","form_type":"8-K","ticker":"VSTM","cik":"0001526119","company_name":"Verastem, Inc.","filed_at":"2024-05-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.830930+00:00","generated_at":"2026-06-01T08:41:36.786062+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Verastem initiates rolling NDA to FDA for avutometinib/defactinib in KRAS mutant LGSOC","bullets":["Rolling submission of NDA seeking accelerated approval for recurrent KRAS mt LGSOC; initial sections include nonclinical and quality.","Clinical module to be submitted in H2 2024 with mature RAMP 201 data including 12-month follow-up; priority review to be requested.","As of Feb 2024 data cutoff: confirmed ORR by BICR 27% overall, 37% (KRAS mt, n=57) and 15% (KRAS wt, n=52); 60% clinical benefit rate ≥6 months.","Discontinuation due to AEs was 9%; median duration of therapy in Part A: 11 months overall, 18 months KRAS mt, 8 months KRAS wt.","No FDA-approved treatments exist for recurrent LGSOC; company plans focused commercial launch targeting top 400 HCPs with 14-18 reps."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-064919","json":"https://secwatch.observer/filing/0001104659-24-064919.json","markdown":"https://secwatch.observer/filing/0001104659-24-064919.md","text":"https://secwatch.observer/filing/0001104659-24-064919.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/0001104659-24-064919-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1526119/000110465924064919/tm2415352d2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T08:41:36.786062+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"}