BioXcel Therapeutics flagged issues related to the recording of safety data at a site for a late-stage trial of its drug to treat agitation in Alzheimer's patients, sending its shares down to a more than three-year low on Thursday.
Dr. Seth Gale points out evidence of Alzheimer’s disease on an MRI at the Center for Alzheimer Research and Treatment at Brigham And Women’s Hospital in Boston, Massachusetts, U.S., March 30, 2023. REUTERS/Brian Snyder/File Photoflagged issues related to the recording of safety data at a site for a late-stage trial of its drug to treat agitation in Alzheimer's patients, sending its shares down to a more than three-year low on Thursday.
This was initially observed by the U.S. Food and Drug Administration after an inspection of the site in December after which the company started an investigation. The company is in the process of hiring an independent auditing group and internal audit results may be available in as early as two or three months, BioXcel's management said on a conference call with analysts.
BioXcel plans to submit an application seeking expanded use of the drug, named BXCL501, to the FDA in the second half of this year.
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