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

Alkermes plc.

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.

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