FDA Grants Breakthrough Therapy Designation to Alkermes' Alixorexton for Narcolepsy Type 1
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Alkermes plc has received Breakthrough Therapy designation from the FDA for its investigational drug alixorexton, aimed at treating narcolepsy type 1. This designation follows positive results from phase 1 and phase 2 clinical trials, including the Vibrance-1 study, which demonstrated significant improvements in wakefulness. Alkermes plans to move alixorexton into phase 3 development in Q1 2026, aiming to expedite the drug's development and review process.
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