secwatch.observer — SEC 8-K summary
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Issuer:     NEUROCRINE BIOSCIENCES INC (NBIX)
CIK:        0000914475
Form:       8-K
Filed at:   2023-10-05T23:59:59+00:00
Accession:  0000914475-23-000065
Event type: other_material
Sentiment:  positive
Materiality: 0.78
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Neurocrine's crinecerfont Phase 3 pediatric CAH study meets primary, key secondary endpoints
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- Primary endpoint: statistically significant decrease in serum androstenedione at Week 4 vs placebo (p=0.0002).
- Key secondary: significant reduction in daily glucocorticoid dose while maintaining androgen control at Week 28 vs placebo (p<0.0001).
- About 30% of crinecerfont patients achieved reduction to physiologic GC dose vs 0% placebo.
- Drug generally well-tolerated; common AEs: headache, fever, vomiting, URI, nasopharyngitis.
- Data to support FDA submission in 2024, with EMA submission to follow.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/914475/000091447523000065/0000914475-23-000065-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/914475/000091447523000065/nbix-20231005.htm
  HTML page:      https://secwatch.observer/filing/0000914475-23-000065

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