secwatch.observer — SEC 8-K summary
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Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2025-09-08T23:59:59+00:00
Accession:  0000950170-25-113379
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alkermes' alixorexton meets primary endpoint in phase 2 NT1 study; all doses improve wakefulness
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- Primary endpoint: MWT mean sleep latency improved by 22.2-26.0 min vs placebo -0.6 min (p<0.01 all doses).
- ESS score normalized (-6.4 to -8.7 vs placebo -3.1, p<0.01); cataplexy rate reduced (6mg p=0.01).
- >40% of 6mg/8mg patients had 100% cataplexy reduction at week 6; improvements in fatigue/cognition.
- No serious TEAEs; common mild-moderate events: pollakiuria, insomnia, salivary hypersecretion, blurred vision.
- Global phase 3 program for alixorexton in NT1 to begin Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000095017025113379/0000950170-25-113379-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000095017025113379/alks-20250908.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-113379

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