BTAI | Market Cap: $27.2M (07/13/26)
Industry:
Pharma & Biotech

DESCRIPTION

BioXcel Therapeutics is a clinical-stage biopharmaceutical company developing treatments for acute agitation in neuropsychiatric and neurodegenerative disorders. Its core asset is BXCL501, a sublingual dissolvable film formulation of dexmedetomidine — a molecule historically used as an IV sedative in ICUs — reformulated to allow rapid, non-invasive self-administration under the tongue. BXCL501 is already FDA-approved as IGALMI for acute agitation in schizophrenia and bipolar disorder in supervised healthcare settings, though commercial revenue remains minimal as BioXcel has scaled back hospital-focused commercial efforts and is focused on regulatory and clinical advancement. The company submitted an sNDA in January 2026 seeking approval for at-home, unsupervised use — a setting with no currently approved treatments — supported by a Phase 3 trial that met its primary safety objective. BioXcel is also pursuing BXCL501 for Alzheimer's agitation, though that program requires an additional Phase 3 trial before an sNDA can be filed. A subsidiary, OnkosXcel, is developing BXCL701 for aggressive cancers, but that program is largely deprioritized due to cash constraints. BioXcel does not manufacture its own product, relying on ARx under an exclusive supply agreement. The company has cut its workforce to 29 employees and is actively seeking partnerships and additional capital to fund operations and a potential broader commercial launch if the at-home sNDA is approved.

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