Alkermes's LUMRYZ Meets Primary Endpoint In Idiopathic Hypersomnia Study

(RTTNews) - Tuesday, Alkermes plc (ALKS) announced positive topline results from the REVITALYZ phase 3 study, evaluating the investigational use of LUMRYZ extended-release oral suspension in adults with idiopathic hypersomnia.

The company stated that LUMRYZ met the primary endpoint by showing statistically significant improvements in excessive daytime sleepiness compared to placebo as measured by the change in Epworth Sleepiness Scale score.

Moreover, the safety profile of LUMRYZ in the REVITALYZ study was generally consistent with previously observed safety data associated with LUMRYZ, with no new safety signals observed in this population.

Moving ahead, the company plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration by 2026 end.

In the pre-market hours, ALKS is trading at $36.39, up 2.59 percent on the Nasdaq.