Axovant Sciences Ltd. (NYSE:AXON) Files An 8-K Other EventsItem 8.01. Other Events.
On January9, 2018, Axovant issued a press release correcting data related to Axovant’s investigational drug nelotanserin previously reported by Axovant in its January8, 2018 press release. In Axovant’s pilot Phase 2 Visual Hallucination study, the post-hoc subset analysis of patients with a baseline Scale for the Assessment of Positive Symptoms – Parkinson’s Disease score of greater than 8.0 was misreported. The Company correctly reported that nelotanserin treatment at 40 mg for two weeks followed by 80 mg for two weeks resulted in a 1.21 point improvement, but the p-value should have been reported as 0.531, unadjusted, instead of 0.011, unadjusted.
A copy of the press release issued January9, 2018 is filed herewith as Exhibit99.1 to this Current Report and is incorporated herein by reference.
Axovant Sciences Ltd. ExhibitEX-99.1 2 a18-2345_2ex99d1.htm EX-99.1 Exhibit 99. 1 FOR IMMEDIATE RELEASE CORRECTION: Axovant Announces Negative Results for Intepirdine in Phase 2b HEADWAY and Pilot Phase 2 Gait and Balance Studies; Positive Trends in Efficacy Seen in Pilot Phase 2 Nelotanserin Study BASEL,…To view the full exhibit click here About Axovant Sciences Ltd. (NYSE:AXON) Axovant Sciences Ltd., formerly Roivant Neurosciences Ltd., is a clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing therapeutics for the treatment of dementia. The Company focuses on developing a pipeline of product candidates to address the cognitive, functional and behavioral aspects of dementia and related neurological disorders. The Company’s focus is to develop its lead product candidate, Intepirdine, which is a selective 5-hydroxytryptamine 6 (5-HT6) receptor antagonist for the treatment of Alzheimer’s disease and dementia with Lewy bodies (DLB). The Company also focuses on developing its second product candidate, Nelotanserin, which is a selective 5-HT2A receptor inverse agonist for the treatment of visual hallucinations in patients with DLB and rapid eye movement (REM) behavior disorder (RBD) in patients with DLB.