{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-046175","form_type":"8-K","ticker":"VSTM","cik":"0001526119","company_name":"Verastem, Inc.","filed_at":"2025-05-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.607593+00:00","generated_at":"2026-05-22T04:06:25.089745+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"FDA approves Verastem's AVMAPKI FAKZYNJA for KRAS-mutated recurrent LGSOC","bullets":["First-ever FDA-approved treatment for KRAS-mutated recurrent LGSOC; accelerated approval based on Phase 2 RAMP 201.","RAMP 201 showed 44% overall response rate (BIRC) in 57 patients; median duration of response range 3.3–31.1 months.","Approval granted May 8, 2025, ahead of the June 30 PDUFA date; continued approval contingent on confirmatory trial.","AVMAPKI FAKZYNJA CO-PACK expected to be commercially available in the U.S. within one week.","Verastem to host investor call at 2:30 pm ET today to discuss the approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-046175","json":"https://secwatch.observer/filing/0001104659-25-046175.json","markdown":"https://secwatch.observer/filing/0001104659-25-046175.md","text":"https://secwatch.observer/filing/0001104659-25-046175.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/0001104659-25-046175-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1526119/000110465925046175/tm2514525d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-22T04:06:25.089745+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"}