(RTTNews) - 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 ...

DUBLIN--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) today announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo ...

Alkermes plc (Nasdaq: ALKS) today announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy ...

DUBLIN--(BUSINESS WIRE)-- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of ...

Alkermes plc (Nasdaq: ALKS) today announced plans to present new data from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at the American Academy of ...

Alixorexton at all doses demonstrated significant improvements from baseline in mean sleep latency compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...

CHICAGO -- Novel orexin receptor 2 agonist oveporexton normalized wakefulness for most people with narcolepsy type 1 in two randomized phase III trials. Mean sleep latency across four, 40-minute ...

– Results From Vibrance-1 to Be Shared in Three Oral Presentations, Including Primary and Secondary Efficacy and Safety Measures, and Exploratory Patient-Reported Outcomes Related to Disease Severity, ...

A Prescription Drug User Fee Act target date for the application has been set for the 3rd quarter of 2026. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...