{"schema_version":"secwatch.filing_event.v1","accession":"0000914475-23-000062","form_type":"8-K","ticker":"NBIX","cik":"0000914475","company_name":"NEUROCRINE BIOSCIENCES INC","filed_at":"2023-09-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.011210+00:00","generated_at":"2026-06-10T21:34:07.809076+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Neurocrine's crinecerfont meets Phase 3 endpoint in CAH adults; FDA submission planned for 2024","bullets":["Phase 3 CAHtalyst Adult study met primary endpoint: significant % reduction in daily glucocorticoid dose with androgen control (p<0.0001).","Key secondary endpoint met: significant decrease in androstenedione at Week 4 vs placebo (p<0.0001).","63% of crinecerfont patients achieved physiologic glucocorticoid dose vs 18% on placebo (p<0.0001).","Company to submit regulatory applications to FDA in 2024 and to EMA afterwards.","Crinecerfont generally well-tolerated; common AEs: fatigue, headache, coronavirus infection."],"urls":{"canonical":"https://secwatch.observer/filing/0000914475-23-000062","json":"https://secwatch.observer/filing/0000914475-23-000062.json","markdown":"https://secwatch.observer/filing/0000914475-23-000062.md","text":"https://secwatch.observer/filing/0000914475-23-000062.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/914475/000091447523000062/0000914475-23-000062-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/914475/000091447523000062/nbix-20230912.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T21:34:07.809076+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"}