---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-270280"
form_type: "8-K"
ticker: "ALKS"
cik: "0001520262"
company_name: "Alkermes plc."
filed_at: "2026-06-15T11:09:44+00:00"
generated_at: "2026-06-15T11:15:30.998863+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Alkermes announces orphan drug designations for alixorexton in US for IH and EU for narcolepsy

## Summary
- FDA grants orphan drug designation to alixorexton for idiopathic hypersomnia.
- European Commission grants orphan drug designation to alixorexton for narcolepsy.
- Alixorexton is an oral OX2R agonist in phase 3 for narcolepsy and phase 2 for IH.
- ODD provides market exclusivity (7 yrs US, 10 yrs EU) if approved.
- Alixorexton previously received FDA Breakthrough Therapy for NT1.

## SEC filing metadata
- accession: 0001193125-26-270280
- form_type: 8-K
- ticker: ALKS
- cik: 0001520262
- company_name: Alkermes plc.
- filed_at: 2026-06-15T11:09:44+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1520262/000119312526270280/0001193125-26-270280-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1520262/000119312526270280/alks-20260615.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-270280
- JSON: https://secwatch.observer/filing/0001193125-26-270280.json
- Plain text: https://secwatch.observer/filing/0001193125-26-270280.txt

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