BioXcel Turns To Commercialization With Positive Phase III Data In Agitation

The company is developing a sublingual thin film of dexmedetomidine that could be used to treat agitation in a wide range of indications after planned initial launches in schizophrenia and bipolar disorder.

soccer ball in goal — BioXcel scored in two Phase III trials • Source: Shutterstock

BioXcel Therapeutics, Inc.'s first potential drug candidate – a sublingual thin film of dexmedetomidine (BXCL501) – met the primary endpoints of two Phase III clinical trials, resulting in rapid and durable reductions in agitation in schizophrenia and bipolar disorder. The company announced the positive data from the SERENITY I and SERENITY II trials on 20 July and said it was turning its focus to regulatory filings and commercialization.

The company is targeting a regulatory filing in the first quarter of 2021 and investors applauded the news. BioXcel's stock price has been growing substantially throughout the year, up 317%...

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