{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-004549","form_type":"8-K","ticker":"UTHR","cik":"0001082554","company_name":"UNITED THERAPEUTICS Corp","filed_at":"2022-01-18T23:59:59+00:00","discovered_at":"2026-05-14T18:04:05.362512+00:00","generated_at":"2026-06-27T17:25:38.249299+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA accepts United Therapeutics' resubmitted NDA for Tyvaso DPI as Class 1 review; target date Feb 2022","bullets":["FDA accepted resubmission of NDA for Tyvaso DPI as a Class 1 response after Complete Response Letter in Oct 2021.","User fee goal date (PDUFA) set for February 2022, indicating expedited review.","Tyvaso DPI is an inhaled treprostinil product for pulmonary arterial hypertension.","Resubmission made on Dec 27, 2021, and accepted for review on Jan 18, 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-004549","json":"https://secwatch.observer/filing/0001104659-22-004549.json","markdown":"https://secwatch.observer/filing/0001104659-22-004549.md","text":"https://secwatch.observer/filing/0001104659-22-004549.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1082554/000110465922004549/0001104659-22-004549-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1082554/000110465922004549/tm223084d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T17:25:38.249299+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"}