Alkermes plc (ALKS), a biopharmaceutical company, on Tuesday reported that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Alixorexton for the treatment of narcolepsy type 1 or NTI.
The designation was based on phase 1 and phase 2 clinical data, including positive results from the phase 2 Vibrance-1 study.
Narcolepsy type 1 is marked by persistent daytime sleepiness, stemming from a deficiency in orexin, a neuropeptide generated in the hypothalamus that serves as a key regulator of wakefulness.
Alixorexton, an investigational, oral, selective orexin 2 receptor (OX2R) agonist, is in development for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).
The Vibrance-1 study was a phase 2, randomized, double-blind, placebo-controlled, dose-range-finding study with 92 participants that evaluated the safety and efficacy of the investigational drug alixorexton in adults with narcolepsy type 1.
In the Vibrance-1 phase 2 study, Alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful, and dose-dependent improvements from baseline compared with placebo on the Maintenance of Wakefulness Test in patients with NT1.
Alixorexton was reported to be generally well-tolerated at all doses tested.
Alkermes look forward to working closely with the FDA as they plan to advance Alixorexton into a phase 3 program in patients with narcolepsy type 1 and type 2 in the first quarter of 2026.
For the third quarter of 2025, Alkermes reported $394.2 million total revenue driven by a 16% year-over-year growth in net sales of its proprietary products, including VIVITROL, ARISTADA and LYBALVI.
ALKS closed Monday's trade at $28, down 0.92%; In the pre-market, ALKS is is trading 1.96% up at $28.55.
For comments and feedback contact: editorial@rttnews.com
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.