{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-059155","form_type":"8-K","ticker":"VNDA","cik":"0001347178","company_name":"Vanda Pharmaceuticals Inc.","filed_at":"2025-12-31T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.206883+00:00","generated_at":"2026-05-16T11:53:27.576955+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA approves Vanda's NEREUS (tradipitant) for motion sickness prevention; first new drug in 40+ years","bullets":["FDA approved NEREUS (tradipitant) on Dec 30, 2025 for prevention of vomiting induced by motion; first new drug class for motion sickness in >40 years.","Pivotal Phase 3 trials: vomiting incidence 18.3-19.5% with NEREUS vs 44.3% placebo (Motion Syros, p<0.0001); 10.4-18.3% vs 37.7% (Motion Serifos, p≤0.0014).","Vanda plans to launch NEREUS in coming months; also advancing tradipitant for gastroparesis and GLP-1 agonist-induced nausea.","Mechanism: NK-1 receptor antagonist, targets substance P pathway underlying nausea/vomiting."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-059155","json":"https://secwatch.observer/filing/0001628280-25-059155.json","markdown":"https://secwatch.observer/filing/0001628280-25-059155.md","text":"https://secwatch.observer/filing/0001628280-25-059155.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/0001628280-25-059155-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/vnda-20251230.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:53:27.576955+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"}