Alkermes' alixorexton meets primary endpoint in phase 2 NT1 study; all doses improve wakefulness

Alkermes plc.

Primary endpoint: MWT mean sleep latency improved by 22.2-26.0 min vs placebo -0.6 min (p<0.01 all doses).
ESS score normalized (-6.4 to -8.7 vs placebo -3.1, p<0.01); cataplexy rate reduced (6mg p=0.01).
>40% of 6mg/8mg patients had 100% cataplexy reduction at week 6; improvements in fatigue/cognition.
No serious TEAEs; common mild-moderate events: pollakiuria, insomnia, salivary hypersecretion, blurred vision.
Global phase 3 program for alixorexton in NT1 to begin Q1 2026.

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