Quarterly ResultMay 15, 2026, 07:12 AM
BioXcel FDA Accepts IGALMI At-Home sNDA; Explores Strategic Options
AI Summary
BioXcel Therapeutics reported a Q1 2026 net loss of $12.7 million, an increase from $7.3 million in Q1 2025, while IGALMI net revenue grew to $206,000. The FDA accepted the supplemental New Drug Application for IGALMI for at-home use in acute agitation associated with bipolar disorders or schizophrenia, setting a PDUFA target action date of November 14, 2026. The company is also actively exploring strategic options with an advisor to maximize shareholder value for the IGALMI franchise and continues to advance its BXCL501 program for Alzheimer’s dementia.
Key Highlights
- FDA accepted sNDA for IGALMI at-home use; PDUFA date set for November 14, 2026.
- BioXcel is exploring strategic options for IGALMI to maximize shareholder value.
- Q1 2026 net loss was $12.7 million, compared to $7.3 million in Q1 2025.
- Q1 2026 IGALMI net revenue was $206,000, up from $168,000 in Q1 2025.
- Research and Development expenses decreased to $3.0 million in Q1 2026 from $4.6 million in Q1 2025.
- Selling, General and Administrative expenses increased to $7.2 million in Q1 2026 from $5.7 million in Q1 2025.
- Cash and cash equivalents totaled $17.2 million as of March 31, 2026.
- Advancing TRANQUILITY In-Care Phase 3 trial for BXCL501 in Alzheimer’s dementia.
Price Impact
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