---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-003453"
form_type: "8-K"
ticker: "ALKS"
cik: "0001520262"
company_name: "Alkermes plc."
filed_at: "2026-01-06T23:59:59+00:00"
generated_at: "2026-05-16T11:31:57.343376+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Alkermes gets FDA Breakthrough Therapy designation for alixorexton in narcolepsy type 1

## Summary
- FDA granted Breakthrough Therapy designation based on phase 1/2 data including Vibrance-1 study (n=92).
- Phase 2 met primary endpoint with dose-dependent improvements in wakefulness vs placebo.
- Alkermes plans to initiate alixorexton global phase 3 program in Q1 2026.
- Alixorexton is an investigational oral selective orexin 2 receptor agonist for NT1, NT2, and IH.

## SEC filing metadata
- accession: 0001193125-26-003453
- form_type: 8-K
- ticker: ALKS
- cik: 0001520262
- company_name: Alkermes plc.
- filed_at: 2026-01-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1520262/000119312526003453/0001193125-26-003453-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1520262/000119312526003453/alks-20260106.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-003453
- JSON: https://secwatch.observer/filing/0001193125-26-003453.json
- Plain text: https://secwatch.observer/filing/0001193125-26-003453.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.