{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-25-004091","form_type":"8-K","ticker":"BCRX","cik":"0000882796","company_name":"BIOCRYST PHARMACEUTICALS INC","filed_at":"2025-06-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.585102+00:00","generated_at":"2026-05-18T21:47:15.284926+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA extends PDUFA goal date for BioCryst's ORLADEYO pediatric NDA to Dec 12, 2025","bullets":["FDA determined submission of additional final reports and formulation data is a major amendment, extending review by three months.","New PDUFA target action date set for December 12, 2025, after original goal date extended.","NDA seeks approval of once-daily ORLADEYO oral granules for HAE in pediatric patients aged 2 to 11 years."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-25-004091","json":"https://secwatch.observer/filing/0001171843-25-004091.json","markdown":"https://secwatch.observer/filing/0001171843-25-004091.md","text":"https://secwatch.observer/filing/0001171843-25-004091.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/0001171843-25-004091-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/882796/000117184325004091/f8k_062525.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T21:47:15.284926+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"}