## Alkermes Advances Alixorexton Narcolepsy Candidate Following FDA Fast-Track Recognition

Alkermes plc (ALKS) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's Breakthrough Therapy designation for Alixorexton, marking acceleration in the development pathway for narcolepsy type 1 treatment. The decision builds upon encouraging clinical evidence from the company's phase 2 Vibrance-1 trial, where the experimental drug demonstrated meaningful therapeutic benefits for patients suffering from this debilitating sleep disorder.

**Understanding the Clinical Challenge**

Narcolepsy type 1 is fundamentally rooted in neurological dysfunction—specifically, insufficient levels of orexin, a critical neuropeptide synthesized within the hypothalamus that maintains wakefulness regulation. This deficiency manifests as relentless daytime sleepiness that significantly impacts patient quality of life. Alixorexton, an orally administered selective orexin 2 receptor (OX2R) agonist, was designed to address this mechanistic gap by restoring wakefulness-promoting signaling pathways. The therapeutic approach is being investigated across multiple related conditions, including narcolepsy type 2 and idiopathic hypersomnia.

**Clinical Trial Results and Drug Safety Profile**

The Vibrance-1 phase 2 investigation enrolled 92 participants in a randomized, double-blind, placebo-controlled design to assess safety and efficacy across varying doses. Results confirmed the primary endpoint, with participants receiving Alixorexton showing statistically and clinically significant, dose-dependent improvements on the Maintenance of Wakefulness Test relative to placebo. Critically, the safety profile remained favorable at all tested dose levels, supporting the candidate's progression toward late-stage development.

**Regulatory Timeline and Commercial Performance**

Alkermes intends to initiate a phase 3 program targeting both narcolepsy type 1 and narcolepsy type 2 beginning in the first quarter of 2026, pending FDA collaboration. Meanwhile, the company's commercial portfolio continues to generate strong momentum. Third-quarter 2025 results reflected $394.2 million in total revenue, powered by 16% year-over-year expansion in proprietary product sales, including established therapies VIVITROL, ARISTADA, and LYBALVI. The stock closed the previous session at $28.00 (down 0.92%), with pre-market activity showing upward momentum at $28.55 (up 1.96%).