BioXcel Therapeutics Receives Positive Findings from Data Integrity Audit, Shares Rise Nearly 20%

BioXcel Therapeutics (Nasdaq: BTAI) has received positive findings from an independent data integrity audit. No evidence of misconduct or fraud was found beyond the instance previously reported and there were no findings identified that impact data integrity. BioXcel’s shares rose nearly 20% following the news.

Based on these findings, BioXcel 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.

Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics., said, “We believe these results of an audit by a respected, independent firm validate the integrity of data from the single site in question and add to the body of clinical evidence we intend to include in our sNDA submission.”

Highlights

BioXcel’s independent audit 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 fraud, and to evaluate data integrity and reliability for eligibility, safety, and efficacy data.

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.

About BioXcel Therapeutics

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications.  For more information, please visit bioxceltherapeutics.com.