{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-25-003152","form_type":"8-K","ticker":"BCRX","cik":"0000882796","company_name":"BIOCRYST PHARMACEUTICALS INC","filed_at":"2025-05-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.584261+00:00","generated_at":"2026-05-21T11:58:34.524277+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA accepts NDA for ORLADEYO granules in HAE ages 2-11; priority review, PDUFA Sep 12, 2025","bullets":["FDA accepted NDA for once-daily ORLADEYO oral granules for HAE patients aged 2-11; priority review granted with PDUFA target Sep 12, 2025.","If approved, ORLADEYO would be first targeted oral prophylactic therapy for HAE under age 12.","NDA based on positive interim APeX-P trial data showing well-tolerated, consistent safety, and reduced monthly attack rates.","BioCryst also filed line extension with EMA; regulatory filings planned in Japan and Canada.","ORLADEYO already approved in US for patients 12+ and commercially available in over 30 countries."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-25-003152","json":"https://secwatch.observer/filing/0001171843-25-003152.json","markdown":"https://secwatch.observer/filing/0001171843-25-003152.md","text":"https://secwatch.observer/filing/0001171843-25-003152.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/0001171843-25-003152-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/882796/000117184325003152/f8k_051425.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T11:58:34.524277+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"}