FDA Grants Breakthrough Therapy Designation to ALKS' Narcolepsy Drug

Key Takeaways Alkermes said the FDA granted Breakthrough status to alixorexton for narcolepsy type 1.ALKS' Vibrance-1 phase II study met its primary endpoint, improving wakefulness versus placebo.Alkermes plans a global phase III program on alixorexton for narcolepsy in Q1 2026. Alkermes (ALKS) announced that the FDA has granted Breakthrough Therapy Designation to alixorexton, a novel, investigational, and oral orexin 2 receptor agonist (formerly ALKS 2680), for the treatment of patients with narcolepsy typ ...