Shots:

• The P-III (SERENITY II) trial evaluates BXCL501 (120/180mcg) vs PBO in patients with acute agitation associated with bipolar disorder
• The 1EP & 2EPs of the study showed the mean changes from baseline in PEC total score @2hrs. after treatment, greater improvement in the PEC total score @120min. after treatment. In prespecified exploratory EPs, patients experienced a treatment response @2hrs. (90.5% & 77.0%), 40% improvement from baseline on PEC score while 46% were treatment responders in the PBO
• The company is expected the US FDA approval of BXCL501 for the acute treatment of agitation associated with bipolar disorders & schizophrenia with an anticipated PDUFA date of April 5, 2022

 Ref: Globe Newswire | Image: BioXcel