Shares of BioXcel Therapeutics Inc. (BTAI) skyrocketed over 40% in premarket trading on Wednesday following the announcement that an independent audit of their Alzheimer's trial data revealed no issues affecting the integrity and reliability of the data.

The audit specifically focused on data obtained from a single site involved in BioXcel's late-stage trial for an experimental treatment targeting Alzheimer's-related agitation in individuals aged 65 and older. Based on the findings of the audit, BioXcel expressed confidence that the phase 3 trial data released in June could support a regulatory application for the approval of their treatment, BXCL501.

Concerns regarding the trial data initially emerged in late June when a regulatory filing by BioXcel stated that they had discovered a principal investigator associated with the trial who may have falsified emails purportedly demonstrating the timely submission of certain safety data. In response, the company promptly launched an investigation and engaged an independent third party to assess the data from the investigator's trial site.

Furthermore, on Wednesday, BioXcel disclosed that no additional instances of misconduct or fraud were found by the audit team.

In recent developments, BioXcel held a meeting with the U.S. Food and Drug Administration (FDA) to discuss their plans for the development of BXCL501. The company anticipates receiving the FDA meeting minutes in the first half of November.

Despite experiencing an 89% dip in share value year-to-date, BioXcel remains optimistic about the future, especially with the positive outcome of the independent audit. In comparison, the S&P 500 index has seen a 10.6% increase.

This news reaffirms BioXcel's commitment to advancing medical research for Alzheimer's and their dedication to ensuring the reliability of trial data. The discovery of no critical issues in the audit bolsters the company's chances of success when seeking regulatory approval for their promising treatment.

Atlas Copco Reports Strong Q3 Results, Expects Near-Term Weakness in Demand

Key Meeting of Anti-Israel Militant Groups

Leave A Reply

Your email address will not be published. Required fields are marked *

Related posts

Melissa McCarthy and Ben Falcone's Atlanta Mansion
News

Melissa McCarthy and Ben Falcone's Atlanta Mansion

Melissa McCarthy and Ben Falcone have listed their luxurious Atlanta mansion, featuring six bedrooms, nine bathrooms, an...

Games Workshop Strikes Exclusive Agreement with Amazon
News

Games Workshop Strikes Exclusive Agreement with Amazon

Games Workshop announces exclusive agreement with Amazon for Warhammer 40,000 films and TV shows, potentially boosting s...

Gasoline Prices Surge for Spring Break
News

Gasoline Prices Surge for Spring Break

Gasoline prices are on the rise, with a national average of $3.338 per gallon, driven by regional disparities, increased...

Federal Judge Grants Temporary Restraining Order to Morgan Stanley Against Former Advisor Team
News

Federal Judge Grants Temporary Restraining Order to Morgan Stanley Against Former Advisor Team

Morgan Stanley has been granted a temporary restraining order against a former advisor team for soliciting clients and t...