secwatch.observer — SEC 8-K summary
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Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2024-04-09T23:59:59+00:00
Accession:  0000950170-24-042791
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

ALKS 2680 shows statistically significant wakefulness improvement in NT2 and IH phase 1b
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- ALKS 2680 improved mean sleep latency vs placebo at all doses in NT2 (5mg: +12 min, p<0.05; 12mg: +19 min, p<0.001; 25mg: +21 min, p<0.001).
- In IH cohort, mean sleep latency improved by 8 min (5mg, p<0.05), 11 min (12mg, p<0.01), and 18 min (25mg, p<0.001).
- No serious AEs or discontinuations; mild transient TEAEs including pollakiuria, insomnia, dizziness at highest dose.
- Phase 2 study in narcolepsy type 2 planned for second half of 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000095017024042791/0000950170-24-042791-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000095017024042791/alks-20240409.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-042791

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