BioXcel Therapeutics (NASDAQ:BTAI) stock is taking a beating on Thursday after the company released its latest clinical trial data.
BioXcel Therapeutics notes that its Phase 3 clinical trial of BXCL501, a treatment of Alzheimer’s disease-related agitation, met its primary and secondary endpoints. However, this was only for the 60mg dose, as the 40mg dose failed to meet the primary endpoint of its positive and negative syndrome scale-excitatory component (PEC) score.
George Grossberg, M.D., Professor and Director of the Division of Geriatric Psychiatry in the Department of Psychiatry & Behavioral Neuroscience at St. Louis University School of Medicine, said this about the trial results:
“In this trial, BXCL501 showed a desirable onset of action and a meaningful reduction in agitation at 2 hours with the 60 mcg dose, and was well tolerated in this patient population. I believe it has potential to be a new treatment option for a condition that not only impacts patients but also caregivers and families.”
BioXcel Therapeutics is preparing to file a supplemental New Durg Application (NDA) with the Food and Drug Administration (FDA) in the second half of 2023.
Why Would This Drop BTAI Stock?
The real problem for investors in BTAI stock comes from a filing related to this clinical trial. In it, the company notes problems with recording safety data. That includes fabricated emails related to the side effects of the trial. While this is only a timing issue, it did unnerve investors this morning.
BTAI stock is down 57.2% as of Thursday morning. That comes as some 3.2 million shares change hands, as compared to its daily average trading volume of about 549,000 shares.
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On the date of publication, William White did not have (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.
