secwatch.observer — SEC 8-K summary
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Issuer:     NEUROCRINE BIOSCIENCES INC (NBIX)
CIK:        0000914475
Form:       8-K
Filed at:   2024-08-28T23:59:59+00:00
Accession:  0000914475-24-000199
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Neurocrine's NBI-1117568 meets Phase 2 primary endpoint; 7.5-point PANSS reduction vs placebo
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- 20 mg once-daily dose met primary endpoint: placebo-adjusted PANSS reduction of 7.5 points (p=0.011, effect size 0.61) at Week 6.
- Dose also statistically significant on CGI-S, Marder positive and negative symptom scores.
- NBI-’568 well tolerated; no weight gain vs placebo; GI events low; discontinuation rates similar to placebo.
- Company plans to advance NBI-’568 into Phase 3 development in schizophrenia in early 2025.
- Other doses (40 mg, 60 mg QD, 30 mg BID) did not reach statistical significance on primary endpoint.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/914475/000091447524000199/0000914475-24-000199-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/914475/000091447524000199/nbix-20240828.htm
  HTML page:      https://secwatch.observer/filing/0000914475-24-000199

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