Key Takeaways ALKS' alixorexton met primary goals in the phase II Vibrance-1 study for narcolepsy type 1. The 6 mg dose was the only one to meet a key secondary goal on cataplexy rates in the study. ALKS plans a global phase III trial as it eyes broader use of alixorexton in sleep disorders.Alkermes (ALKS) announced positive top-line data from the phase II Vibrance-1 study, which evaluated its novel, investigational, and oral orexin 2 receptor agonist, alixorexton (formerly ALKS 2680), for treating patien ...

Core Viewpoint - Axsome Therapeutics has reached a settlement with Hetero Labs regarding patent litigation over its product SUNOSI, allowing Hetero to market a generic version under specific conditions starting in 2040 [1][2]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness, and migraines [3]. Settlement Details - The settlement permits Hetero to sell a generic version of SUNOSI starting on or after September 1, 2040, if pediatric exclusivity is granted, or on or after March 1, 2040, if not, contingent upon FDA approval [1]. - The agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review [2]. Ongoing Litigation - Axsome continues to pursue similar patent litigation against other parties related to SUNOSI in the U.S. District Court for the District of New Jersey [2].