{"schema_version":"secwatch.filing_event.v1","accession":"0001356576-25-000002","form_type":"8-K","ticker":"SUPN","cik":"0001356576","company_name":"SUPERNUS PHARMACEUTICALS, INC.","filed_at":"2025-01-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.419605+00:00","generated_at":"2026-05-27T09:05:59.344109+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Supernus announces FDA label update for Qelbree with new pharmacodynamic and lactation data","bullets":["FDA approved updated Qelbree label including serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition data.","New lactation data show transfer of viloxazine into breastmilk is low; relative infant dose ~1% of maternal dose.","Qelbree is first ADHD treatment to receive labeling approval under 2019 FDA guidance on Clinical Lactation Studies.","Label update applies to Qelbree (viloxazine extended-release capsules) for ADHD in patients 6 years and older.","Company cites commitment to building evidence for Qelbree use in ADHD."],"urls":{"canonical":"https://secwatch.observer/filing/0001356576-25-000002","json":"https://secwatch.observer/filing/0001356576-25-000002.json","markdown":"https://secwatch.observer/filing/0001356576-25-000002.md","text":"https://secwatch.observer/filing/0001356576-25-000002.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1356576/000135657625000002/0001356576-25-000002-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1356576/000135657625000002/supn-20250127.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T09:05:59.344109+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"}