secwatch.observer — SEC 8-K summary
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Issuer:     Alkermes plc. (ALKS)
CIK:        0001520262
Form:       8-K
Filed at:   2023-10-23T23:59:59+00:00
Accession:  0000950170-23-054504
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alkermes reports Phase 1 data for ALKS 2680 showing significant sleep latency improvement in narcolepsy type 1
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- ALKS 2680 demonstrated dose-dependent improvement in sleep latency: +18, +30, +37 minutes vs placebo (-1 min) at 1, 3, 8 mg (p<0.01 to p<0.001).
- At 8 mg dose, patients maintained wakefulness for full 40-minute MWT up to 10 hours post-dose.
- ALKS 2680 generally well tolerated; mild AEs at 8 mg (insomnia, pollakiuria, salivary hypersecretion); no serious AEs.
- PK profile supports once-daily oral dosing; Phase 2 study planned for H1 2024.
- First cohort (4 NT1 patients) data presented at World Sleep Congress; study also enrolling NT2 and IH patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1520262/000095017023054504/0000950170-23-054504-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1520262/000095017023054504/alks-20231023.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-054504

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