{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-25-007909","form_type":"8-K","ticker":"BCRX","cik":"0000882796","company_name":"BIOCRYST PHARMACEUTICALS INC","filed_at":"2025-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.459183+00:00","generated_at":"2026-05-16T13:26:29.099597+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BioCryst gets FDA approval for ORLADEYO oral pellets for HAE patients aged 2 to <12 years","bullets":["FDA approved ORLADEYO oral pellet formulation for prophylactic therapy in HAE children aged 2 to <12 years.","First and only oral prophylactic treatment for this age group; previously only injectable options were available.","Approval supported by APeX-P trial interim data showing early and sustained attack rate reductions with no new safety signals.","BioCryst plans EU, Japan, and other regulatory filings; ORLADEYO capsule already approved for ages 12+ since Dec 2020.","More than 3,500 patients in the US have been prescribed ORLADEYO to date."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-25-007909","json":"https://secwatch.observer/filing/0001171843-25-007909.json","markdown":"https://secwatch.observer/filing/0001171843-25-007909.md","text":"https://secwatch.observer/filing/0001171843-25-007909.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/882796/000117184325007909/0001171843-25-007909-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/882796/000117184325007909/f8k_121225.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:26:29.099597+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"}