{"schema_version":"secwatch.filing_event.v1","accession":"0001356576-24-000041","form_type":"8-K","ticker":"SUPN","cik":"0001356576","company_name":"SUPERNUS PHARMACEUTICALS, INC.","filed_at":"2024-08-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.772027+00:00","generated_at":"2026-05-31T13:42:57.722412+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Supernus resubmits NDA for SPN-830 apomorphine infusion for Parkinson's OFF episodes","bullets":["Resubmitted NDA for SPN-830 (apomorphine infusion device) to FDA for continuous treatment of OFF episodes in Parkinson's disease.","CRL in April 2024 identified two areas needing additional info; no clinical safety or efficacy issues were raised.","Company believes it has fully addressed the FDA's questions from the CRL.","If approved, SPN-830 could be an important novel therapy for Parkinson's patients.","Supernus will continue to work closely with the FDA during the NDA review process."],"urls":{"canonical":"https://secwatch.observer/filing/0001356576-24-000041","json":"https://secwatch.observer/filing/0001356576-24-000041.json","markdown":"https://secwatch.observer/filing/0001356576-24-000041.md","text":"https://secwatch.observer/filing/0001356576-24-000041.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1356576/000135657624000041/0001356576-24-000041-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1356576/000135657624000041/supn-20240801.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T13:42:57.722412+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"}