According to a press release from the company, a third-party audit of its Phase 3 study returned positive results. BioXcel Therapeutics notes that this audit focused on one of its sites used in the clinical trial.
The audit covered more than 50% of patients taking part in the trial. The results didn’t show any evidence of additional misconduct or fraud and also backed up data reliability and integrity with 95% confidence in the data reviewed acting as a representative sample.
Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, said the following in the news release:
“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.”
What’s Next for BTAI Stock?
With this data in hand, BioXcel Therapeutics is preparing for a meeting with the U.S. Food and Drug Administration (FDA). It seeks to cover further development plans for BXCL501 as a treatment for agitation “associated with dementia in probable Alzheimer’s disease.”
Investors will want to keep an eye on BTAI stock when that meeting rolls around. Currently, it expects this to take place in the first half of November.
BTAI stock is up 41.5% as of Wednesday morning.
Investors on the lookout for even more of the most recent stock market news will want to keep reading!
We have all of the biggest stock market stories traders need to know about on Wednesday. Among that is what has shares of InMed Pharmaceuticals (NASDAQ:INM), Reshape Lifesciences (NASDAQ:RSLS) and Sonnet BioTherapeutics (NASDAQ:SONN) stock moving today. All of that news is ready to go down below!
More Stock Market News for Tuesday
- Why Is InMed Pharmaceuticals (INM) Stock Down 25% Today?
- Why Is Reshape Lifesciences (RSLS) Stock Up 59% Today?
- Why Is Sonnet BioTherapeutics (SONN) Stock Down 33% Today?
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.