2023-05-25 12:40:13 ET
Shares of BioXcel Therapeutics (NASDAQ: BTAI) were down more than 19% early Thursday afternoon after the biotech company released the first part of a phase 3 trial for the therapy BXCL501 (dexmedetomidine) to treat acute agitation in bipolar disorders or schizophrenia.
The study was based on at-home use of the therapy on patients by their caregivers. The drug, marketed under the name Igalmi (dexmedetomidine), was approved by the Food and Drug Administration (FDA) last April in a sublingual film to treat bipolar and schizophrenia patients in medical settings, but the additional indication was for at-home use. The part of the study that worried investors is the therapy didn't meet its primary endpoint. Measured at two hours after the dose, the change in Positive and Negative Syndrome Scale, Excited Component, though it differed from that with placebo, did not reach statistical significance, the company said.
The drug is also in trials to treat acute agitation in major depressive disorder and Alzheimer's disease.
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Why Shares of BioXcel Therapeutics Are Dropping Thursday