BioXcel: Positive Findings from Data Integrity at Phase 3 Trial

 No evidence of misconduct or fraud found beyond instance previously reported1

No findings identified that impact data integrity

Company believes audit findings support reliability of positive TRANQUILITY II trial data and potential sNDA submission

“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,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We recently had a Type B/Breakthrough meeting with the FDA to discuss our plans for the development of BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer’s disease. We expect to receive the FDA meeting minutes in the first half of November, and intend to provide an update on additional steps for the TRANQUILITY program and a potential sNDA in our upcoming third quarter financial results.”

https://www.globenewswire.com/news-release/2023/10/25/2766353/0/en/BioXcel-Therapeutics-Announces-Positive-Findings-from-Independent-Third-Party-Audit-of-Data-Integrity-at-TRANQUILITY-II-Phase-3-Trial-Site.html