BioXcel Therapeutics (NASDAQ:BTAI) added ~41% pre-market Wednesday after announcing that an independent third-party audit found no data integrity issues in the company's TRANQUILITY II Phase 3 trial for Alzheimer's candidate BXCL501.
Shares of the New Haven, Connecticut, biotech fell in June despite reporting positive findings from TRANQUILITY II amid concerns about how a study site, which accounted for approximately 40% of subjects, conducted the trial.
"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," BioXcel (BTAI) said.
TRANQUILITY II was designed to test BXCL501 for the acute treatment of Alzheimer's-linked agitation in older adults living in assisted living facilities and in residential care sites who required minimal support for their daily activities.
Based on the audit findings, the company thinks that positive data reported in June would support a potential supplemental new drug application for BXCL501 in the targeted population.