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Investing.com --Alkermes Plc (NASDAQ:ALKS)stock rose 3.4% in premarket trade Tuesday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to the company’s experimental drug alixorexton for the treatment of narcolepsy type 1 (NT1).
The designation, which is designed to expedite development and review of drugs that may offer substantial improvements over existing therapies, was based on phase 1 and phase 2 clinical data, including positive results from the Vibrance-1 study.
In the phase 2 trial, which included 92 patients with NT1, alixorexton demonstrated statistically significant and dose-dependent improvements in wakefulness compared to placebo, meeting the primary endpoint across all doses tested. The drug was generally well tolerated at all doses.
"This Breakthrough Therapy designation underscores the strength of alixorexton’s initial clinical data and supports our conviction that targeting the orexin pathway has the potential to fundamentally shift treatment expectations for central disorders of hypersomnolence," said Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.
Alixorexton is an oral, selective orexin 2 receptor agonist being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. The company plans to advance the drug into phase 3 development later this quarter, with a global phase 3 program expected to begin in the first quarter of 2026.
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