other_material
confidence high
sentiment positive
materiality 0.80
Alkermes reports positive phase 2 results for alixorexton in narcolepsy type 1; primary endpoint met
Alkermes plc.
- Alixorexton met primary endpoint: statistically significant and dose-dependent improvements in wakefulness (MWT) vs placebo (p<0.0001 at all doses).
- Key secondary: ESS improved significantly at all doses (p<0.0001); weekly cataplexy rates numerically improved, significant at 6 mg (p=0.005).
- Exploratory endpoints: alixorexton improved disease severity (NSS), cognition (BC-CCI), and fatigue (PROMIS-Fatigue) at all doses (p<0.01).
- Alixorexton was generally well tolerated; no serious AEs; >95% of patients entered open-label extension.
- Data support rapid initiation of global phase 3 program in NT1; detailed results at World Sleep Congress Sept 2025.
item 7.01item 9.01