Shares of BioXcel Therapeutics Inc (NASDAQ:BTAI) surged on Wednesday in response to an encouraging development related to its investigational therapeutic, BXCL501. The artificial intelligence (AI)-powered biopharmaceutical company disclosed that an independent audit of a late-stage trial site aimed at treating agitation in Alzheimer’s patients found no evidence of any misconduct or fraud beyond what was previously reported.
At the time of this publication, BioXcel Therapeutics Inc stock (BTAI) has witnessed a surge.
BioXcel Therapeutics Inc
Current Price: $2.85
Change : +0.51
Change (%): (21.75%)
Volume: 57.6M
Source: Tomorrow Events Market Data
In a company-issued press release, BioXcel revealed that a third-party audit of its Phase 3 study yielded positive outcomes. Earlier this year, in June 2023, the company had raised concerns about the recording of safety data at a site within its TRANQUILITY II Phase 3 trial. Specifically, it was suspected that a principal investigator might have fabricated emails indicating timely submission of certain safety data. This revelation led to a dramatic 63% drop in BioXcel Therapeutics’ shares within a single day.
BioXcel clarified that the independent audit encompassed a thorough examination of records from over 50% of the enrolled subjects at the specific trial site. The objective was to identify any potential additional instances of misconduct or fraud and to assess the integrity and reliability of data related to eligibility, safety, and efficacy.
The company emphasized that the selected sample size carries a 95% confidence level, ensuring that the data reviewed is a statistically representative sample. Auditors concluded that no findings were identified that could jeopardize data reliability or integrity, nor did they uncover any additional evidence of misconduct or fraud.
Given this positive outcome, BioXcel is optimistic that the trial data disclosed in June could serve as a foundation for a supplemented new drug application (sNDA) for BXCL501 in the treatment of agitation linked to dementia in probable Alzheimer’s disease.
Dr. Vimal Mehta, CEO of BioXcel, stated, “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.”
Recently, the company engaged in a Type B/Breakthrough meeting with the United States Food and Drug Administration (FDA) to discuss the developmental trajectory of BXCL501. Dr. Mehta added, “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.”
Despite this positive development, BioXcel still faces a considerable path to regain its share price, which stood at approximately US$17 prior to the disclosure of trial issues in June. Year to date, the stock has declined by 85.4%.
