Harmony Biosciences Holdings Inc. has announced an exclusive licensing agreement with Bioprojet Pharma SAS to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin OX2 receptor agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders.
Teijin Pharma Ltd. has entered into an exclusive global licensing agreement with Bioprojet under which Teijin Pharma grants Bioprojet Pharma SAS exclusive worldwide rights to research, develop, manufacture and commercialize an investigational candidate for narcolepsy.
An asset that some investors may have overlooked came through for Axsome Therapeutics Inc., which rolled out phase III data from the trial called Symphony with AXS-12 (reboxetine), which hit the primary endpoint by significantly reducing cataplexy attacks in narcolepsy patients vs. placebo.
NLS Pharmaceutics Ltd. has entered into an exclusive worldwide license agreement with Aexon Labs Inc. granting NLS the opportunity to acquire global development and commercialization rights to Aexon’s next-generation nonsulfonamide dual orexin receptor agonists platform.
Researchers from Centessa Pharmaceuticals plc presented the preclinical characterization of ORX-750, a novel selective orexin receptor 2 (OX2R) agonist aimed to be used for the treatment of narcolepsy.
Despite its promising therapeutic efficacy in patients with narcolepsy type 1, the previously reported orally available orexin OX2 receptor (OX2R) agonist TAK-994 has also demonstrated off-target liver toxicity. Now, researchers from Takeda Pharmaceutical Co. Ltd. have reported the discovery and early evaluation of a new OX2R agonist, TAK-861, being developed for the treatment of narcolepsy and other hypersomnia disorders.
Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down.