What happened
Shares of BioXcel Therapeutics (BTAI -9.09%), a commercial-stage biopharmaceutical company that uses artificial intelligence to develop neuroscience and immuno-oncology therapies, rose 12.9% this week, according to data from S&P Global Market Intelligence.
The stock closed last Friday at $13.11, but jumped to $14.86 late Wednesday. The stock has a 52-week low of $12.33 and a 52-week high of $39 and is still down more than 33% this year.
Image source: Getty Images.
Now what
The company didn't release any new financial data as its first-quarter earnings report is scheduled for May 9. The reason for the rise is, on Tuesday after the market closed, the company announced that it had dosed its first patient in its phase 3 Tranquility II study of its lead therapy, Igalmi (BXCL501), to treat agitation in patients with Alzheimer's disease.
Igalmi, a sublingual (under the tongue) film formulation of dexmedetomidine, was just approved in April by the Food and Drug Administration (FDA) for the acute treatment of agitation connected with schizophrenia or bipolar I or II disorder in adults. The quick move to expand the label of the drug was news enough to move the needle for investors.
So what
Caution is necessary with BioXcel because there are so many unknowns. The company didn't have any revenue in 2020 and lost $106.9 million. As of Dec. 31, 2021, it reported it had enough cash -- $233 million -- to get it through two more years at its current burn rate. However, the opportunity for Igalmi is a strong one, particularly if it can be approved for use with Alzheimer's-related agitation.
Alzheimer's is the most common form of dementia in the United States, according to data from the Alzheimer's Association. In 2022, the number of patients age 65 and over with Alzheimer's was estimated at 6.5 million, but by 2050, that number was expected to nearly double to 12.7 million, according to the association. BioXcel said nearly 70% of those adults with Alzheimer's experience agitation, so that's a huge potential market for Igalmi and there are no current approved therapies for agitation associated with the disease.
Now what
Investors will parse the healthcare company's first-quarter numbers later this month to see if its planned launch of Igalmi is having much of an effect on expenses. Since the drug isn't expected to launch until the second quarter, it's unlikely to help with revenue until later in the year. The company is also looking to see if Igalmi can be approved as a therapy to treat agitation in patients with major depressive disorder.
