Alkermes plc ( ALKS ) released topline results on Wednesday from the Vibrance-2 dose-ranging phase 2 study evaluating alixorexton (formerly ALKS 2680) in narcolepsy type 2 (NT2).

Narcolepsy type 2, also known as narcolepsy without cataplexy, is a sleep disorder characterized by excessive daytime sleepiness (EDS). Unlike type 1, it typically does not include cataplexy (sudden muscle weakness triggered by emotions).

In the trial, once-daily alixorexton met the dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements from baseline compared to placebo on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight.

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Alixorexton demonstrated clinically meaningful improvements from baseline in mean sleep latency compared with placebo at week eight across all doses tested. The 14 mg and 18 mg doses achieved statistical significance.

Alixorexton demonstrated clinically meaningful improvements from baseline in excessive daytime sleepiness compared to placebo on the ESS at week eight at all doses tested. The 18 mg dose achieved statistical significance.

Alixorexton was generally well tolerated across all doses tested during the eight-week randomized, double-blind treatment period. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No serious TEAEs were reported.

Results from Vibrance-2 and the previously announced Vibrance-1 phase 2 study in patients with NT1 support rapid initiation of a global phase 3 program of alixorexton in patients with NT1 and NT2.

Alkermes ( ALKS ) plans to present detailed results from the Vibrance-2 phase 2 study, including exploratory patient-reported outcomes related to cognition and fatigue, at a future scientific meeting.

Alkermes ( ALKS ) plans to initiate the alixorexton narcolepsy global phase 3 program in the first quarter of 2026.

Vibrance-3 phase 2 study evaluating the safety and efficacy of alixorexton in adults with idiopathic hypersomnia is currently enrolling.

Price Action: ALKS stock is down 8.03% at $31.1 at the last check on Wednesday.

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