secwatch.observer — SEC 8-K summary
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Issuer:     NEUROCRINE BIOSCIENCES INC (NBIX)
CIK:        0000914475
Form:       8-K
Filed at:   2023-09-12T23:59:59+00:00
Accession:  0000914475-23-000062
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Neurocrine's crinecerfont meets Phase 3 endpoint in CAH adults; FDA submission planned for 2024
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/914475/000091447523000062/0000914475-23-000062-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/914475/000091447523000062/nbix-20230912.htm
  HTML page:      https://secwatch.observer/filing/0000914475-23-000062

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer