BioXcel Therapeutics Reports Positive Independent Third-Party Findings from TRANQUILITY II Phase 3 Trial

DENVER, Colo., Oct 25, 2023 ( BioXcel Therapeutics Inc (NASDAQ:BTAI) reported, this morning, positive findings from an independent third-party audit of the data from a single site in its TRANQUILITY II Phase 3 trial. The independent audit was conducted by a consulting firm and consisted of a comprehensive review of records from over 50% of subjects enrolled at the single trial site to identify any additional instance of misconduct or fraud2 and to evaluate data integrity and reliability for eligibility, safety, and efficacy data. This sample size provides 95% confidence that the data reviewed is a representative sample. Following an extensive review, the team of auditors did not identify any findings that they believe impact the data reliability or integrity, nor did they find any evidence of additional misconduct or fraud. Based on these findings, BioXcel Therapeutics believes that the positive, statistically significant TRANQUILITY II trial data announced in June 2023 potentially support a supplemental new drug application (sNDA) for BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer’s disease.

BioXcel Therapeutics is trading at $2.57, up $0.23 (+9.83%), on 282.9K premarket shares traded.

Its 52-week range is $2.23 to $34.125. It hit a new 52-week low, on Monday, from a low volume downward move, so this could make a strong reversal higher.

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