Mizuho ‘very disappointed’ by BioXcel’s AD data update

Mizuho notes that BioXcel Therapeutics announced mixed top-line results from the Phase 3 TRANQUILITY II study for lead asset BXCL501 for treatment of Alzheimer’s disease, or AD, agitation and in a separate 8-K filing disclosed information relating to the data integrity of the T2 study. The firm “came away very disappointed on the totality” of the data update, says the analyst. While “on the surface” the higher 60ug dose did demonstrate statistical significance, which is “a win on paper,” the firm believes that “in the worst case scenario” the ongoing FDA investigation calls into question the data where the clinical site enrolled 40% of patients. Shares are down 60% intraday, which the firm believes reflects lost confidence in management and the overall BioXcel story among investors, and it believes the FDA investigation will overshadow ‘501 achieving the primary endpoint. Mizuho has a Buy rating and $40 price target on BioXcel shares.