BioXcel Therapeutics (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the fourth quarter and full year ended December 31, 2025.
The company’s strategic focus remains centered on the expansion of its lead product, IGALMI™ (dexmedetomidine) sublingual film, from its current acute care indication into the significantly larger at-home treatment market.
A major operational milestone was achieved in January 2026 with the formal submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA).
The application seeks approval for IGALMI for the at-home treatment of agitation associated with bipolar disorders and schizophrenia.
The submission is bolstered by data from the SERENITY At-Home Phase 3 trial, which demonstrated a strong correlation between patient/caregiver-scored efficacy and clinician-scored outcomes, alongside a safety profile consistent with the current hospital-use label.
BioXcel is targeting potential FDA approval as early as the end of 2026.
Financially, BioXcel reported full-year 2025 net revenue from IGALMI of $642,000, reflecting the initial stages of its commercial rollout within the healthcare facility setting.
The company ended the year with $28.8 million in cash, cash equivalents, and restricted cash.
This liquidity position follows a period of heavy investment in the SERENITY clinical program and ongoing commercial infrastructure build-out.