BioXcel Reports Positive Findings From Third Party Audit Of Data Integrity At Phase 3 Trial Site

(RTTNews) - BioXcel Therapeutics Inc. (BTAI) announced positive findings from an independent third party audit of the data from a single site in its TRANQUILITY II Phase 3 trial. The company believes audit findings support reliability of positive TRANQUILITY II trial data and potential supplemental new drug application submission.

Following the announcement, the company's shares are soaring more than 35 percent in pre-market trading.

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 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 said it recently had a Type B/Breakthrough meeting with the FDA to discuss its plans for the development of BXCL501 for the acute treatment of agitation associated with dementia in probable Alzheimer's disease.

The company expects to receive the FDA meeting minutes in the first half of November, and intends to provide an update on additional steps for the TRANQUILITY program and a potential sNDA in its upcoming third quarter financial results.

BTAI closed Tuesday's regular market trading at $2.34 up $0.02 or 0.86%. In Wednesday pre-market trading, the stock gained $0.83 or 35.47%.

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