Alkermes plc Announces Orphan Drug Designations for Alixorexton

Alkermes plc announced on June 15, 2026, that alixorexton has received orphan drug designations from regulatory bodies in the U.S. and Europe. The U.S. Food and Drug Administration (FDA) granted the designation for the treatment of idiopathic hypersomnia (IH), while the European Commission granted it for the treatment of narcolepsy. Alixorexton is an investigational oral selective orexin 2 receptor agonist being developed for narcolepsy types 1 and 2, and idiopathic hypersomnia. These designations provide incentives for rare disease drug development, including market exclusivity if approved. Alixorexton previously received Breakthrough Therapy designation from the FDA for narcolepsy type 1. The company is currently advancing alixorexton through Phase 3 studies for narcolepsy and a Phase 2 study for IH. The press release also provides background information on narcolepsy and idiopathic hypersomnia, describes alixorexton, and includes forward-looking statements regarding the drug's development and potential.