What happened
Shares of the commercial-stage biopharma BioXcel Therapeutics (BTAI 4.21%) were up by 10.3% on heavy volume as of 3:29 p.m. ET Monday afternoon. The big gain came after the drugmaker reported 2023 first-quarter earnings ahead of the opening bell this morning.
On the financial side, BioXcel reported $206,000 in net revenue from its Food and Drug Administration (FDA) approved treatment, Igalmi, for agitation associated with schizophrenia or bipolar disorder during the three-month period. Igalmi, a sublingual formulation of dexmedetomidine, was approved by the FDA in this setting in April of 2022.
So what
Igalmi's rather modest sales probably weren't the spark behind today's double-digit rally. Instead, investors appear to be piling into the biotech ahead of key data readouts for BXCL501 in other agitation settings, as well as in major depressive disorder (MDD).
Specifically, BioXcel announced during today's earnings release that top-line data for BXCL501's late-stage trial as a home-based treatment for bipolar or schizophrenia-associated agitation should be available later this month. What's more, the drug's phase 1b MDD data in healthy volunteers are also due out in May. Topping it off, BioXcell plans to unveil BXCL501's top-line results from its phase 3 trial as a treatment for acute agitation associated with Alzheimer's disease this coming June.
Now what
Is BioXcel's stock still worth buying after today's rally? It all depends on your comfort with risk. BXCL501 could be a major value driver for the company if it can hit in one or more of these indications. Drugs targeting disorders of the central nervous system are inherently high-risk. As such, investors should probably keep any starter position on the small side ahead of these clinical catalysts.