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Takeda ((TAK) will present today positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. TAK-861 is an investigational oral orexin receptor 2 (OX2R) agonist and, based on the results, has the potential to provide transformative efficacy in addressing the overall disease burden in people with NT1. The randomized, double-blind, placebo-controlled, multiple dose trial, TAK-861-2001 (NCT05687903), in 112 patients with NT1 demonstrated statistically significant and clinically meaningful improvements across primary and secondary endpoints, with efficacy sustained over 8 weeks of treatment.*
NT1 is a chronic, rare neurological central disorder of hypersomnolence caused by a significant loss of orexin neurons, resulting in low levels of orexin neuropeptides in the brain and cerebrospinal fluid. No currently approved treatments target the underlying pathophysiology of NT1. People with NT1 suffer from excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hypnagogic and hypnopompic hallucinations and sleep paralysis. These debilitating symptoms lead to a markedly reduced quality of life and can severely impact job performance, academic achievement and personal relationships. TAK-861 is designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2.
The presentation highlights results from the Phase 2b trial including:
Posted In: TAK