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      Following The Validation Of Trial Results, BioXcel (BTAI) Stock Is Rising

      By Fahim Awan

      Published on

      October 25, 2023

      5:19 PM UTC

      Following The Validation Of Trial Results, BioXcel (BTAI) Stock Is Rising

      BioXcel Therapeutics, Inc. (NASDAQ: BTAI) shares have exhibited a notable surge of 23.08%, reaching $2.88 in the present trading session, as per the most recent data.

      The BioXcel stock was trading in a range spanned from $2.83 to $3.35 during today’s market activity, with a substantial trading volume of over 50 million shares.

      The catalyst for this morning’s ascent in BTAI stock can be attributed to a positive evaluation by an external party concerning the results of its clinical trial.

      Today, BioXcel (BTAI) unveiled encouraging outcomes stemming from an impartial third-party assessment of data from a specific site within its TRANQUILITY II Phase 3 trial.

      This audit, conducted by a well-respected regulatory and quality consulting firm, involved a thorough scrutiny of records pertaining to more than 50% of the trial’s participants at that specific site.

      The primary objectives of the audit encompassed the detection of any potential irregularities, misconduct, or fraudulent activities and an assessment of the integrity and reliability of the data pertaining to eligibility, safety, and efficacy.

      The sample size employed in this assessment ensures a 95% confidence level in the representativeness of the data reviewed.

      Following a comprehensive examination, the team of auditors did not uncover any elements that could compromise the reliability or integrity of the data, nor did they unearth any indications of further misconduct or fraud.

      Based on these findings, BioXcel has the belief that the positive and statistically significant data from the TRANQUILITY II trial, as announced in June 2023, could potentially serve as a basis for a supplemental new drug application (sNDA) for BXCL501, aimed at the acute treatment of agitation associated with dementia in probable Alzheimer’s disease.

      BioXcel is of the opinion that the results of this audit, conducted by a respected and independent entity, affirm the trustworthiness of the data originating from the specific site under scrutiny.

      Furthermore, these results enrich the body of clinical evidence that the company intends to incorporate into its sNDA submission.

      Notably, BTAI has recently conducted a Type B/Breakthrough meeting with the FDA to discuss the development plans for BXCL501 concerning the acute treatment of agitation in the context of dementia related to probable Alzheimer’s disease.

      BioXcel anticipates the receipt of the FDA meeting minutes in the first half of November and intends to provide an update on the subsequent phases of the TRANQUILITY program and the potential sNDA in its forthcoming third-quarter financial report.

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