ALKS 2680 - (Vibrance-1)

August 24, 2026: Alkermes plc (NASDAQ: ALKS) announced publication in The Lancet Neurology of phase 2 Vibrance-1 data for alixorexton in adults with narcolepsy type 1. In the 92-patient, randomized, placebo-controlled, double-blind study, once-daily alixorexton (4 mg, 6 mg, 8 mg) produced statistically significant improvements versus placebo in wakefulness and excessive daytime sleepiness, measured by Maintenance of Wakefulness Test and Epworth Sleepiness Scale at week 6. All dose groups reached normative-range mean values on MWT (at least 20 minutes) and ESS (10 or less). Weekly cataplexy rate was significantly reduced versus placebo in the 6 mg group.

The company said alixorexton also showed clinically meaningful improvements on exploratory patient-reported measures of disease severity, fatigue, cognition, and health-related quality of life. It was generally well tolerated, with most treatment-emergent adverse events mild to moderate and no serious TEAEs reported.

Alixorexton is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. The company said its global phase 3 Brilliance studies are underway in NT1 and NT2, and the phase 2 Vibrance-3 study is ongoing in idiopathic hypersomnia. The FDA has granted Breakthrough Therapy designation for NT1 and Orphan Drug Designation for IH.