BioXcel aligns with FDA recommendation for Phase 3 trial for TRANQUILITY

BioXcel Therapeutics announced alignment with the FDA’s recommendation for a Phase 3 trial in the TRANQUILITY program. In addition, the Company provided an update on strategic financing activities that would enable greater operational flexibility and reported its financial results for the third quarter ended Sept. 30, 2023. “This is a time of tremendous progress and excitement for our company and stakeholders, especially as we report a clinical development path forward for our TRANQUILITY program,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “I am proud of the teamwork that enabled us to turn our focus to much larger potential opportunities for BXCL501 in at-home settings, beginning with agitation associated with Alzheimer’s dementia. Furthermore, we believe FDA feedback in the recent meeting focused on the SERENITY III program provides a clear path to develop BXCL501 for at-home use in the treatment of agitation associated with schizophrenia and bipolar disorders. When we couple these positive developments with revised terms with our strategic financing partners, we believe we have a strong foundation to deliver success.”