Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational drug alixorexton for the treatment of narcolepsy type 1. This designation is based on positive phase 1 and phase 2 clinical data, including results from the Vibrance-1 phase 2 study. Alixorexton, a selective orexin 2 receptor agonist, showed significant improvements in wakefulness compared to placebo and was generally well tolerated. The Breakthrough Therapy designation is intended to expedite the development and review process for drugs that may offer substantial improvement over existing therapies. Alkermes plans to advance alixorexton into phase 3 development in the first quarter of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alkermes plc published the original content used to generate this news brief via Business Wire (Ref. ID: 20260106871102) on January 06, 2026, and is solely responsible for the information contained therein.