Shots:

• The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II- respectively
• Results: BXCL501 met its 1EPs & 2EPs in both the studies- demonstrating rapid- and durable improvements from baseline across multiple agitation scales
• The company is anticipating the PDUFA date as Jan 05- 2022. BXCL501 is investigational- orally dissolving thin film formulation of dexmedetomidine

  Ref: GLOBE NEWSWIRE | Image: BioXcel