USFDAMay 15, 2026, 07:02 AM
BioXcel FDA Accepts IGALMI® At-Home sNDA; PDUFA Nov 14
AI Summary
BioXcel Therapeutics announced that the FDA accepted its supplemental New Drug Application (sNDA) 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. Concurrently, the company is evaluating strategic options with an advisor to maximize shareholder value for the IGALMI franchise. For Q1 2026, BioXcel reported a net loss of $12.7 million, an increase from $7.3 million in Q1 2025, with IGALMI® net revenue at $206,000 and cash reserves of $17.2 million.
Key Highlights
- FDA accepted sNDA for IGALMI® for at-home use in bipolar/schizophrenia agitation.
- PDUFA target action date for IGALMI® at-home use is November 14, 2026.
- BioXcel is exploring strategic options for the IGALMI franchise to maximize shareholder value.
- Q1 2026 IGALMI® net revenue was $206,000, up from $168,000 in Q1 2025.
- Q1 2026 Net loss increased to $12.7 million, compared to $7.3 million in Q1 2025.
- Cash and cash equivalents totaled $17.2 million as of March 31, 2026.
- R&D expenses decreased to $3.0 million in Q1 2026 from $4.6 million in Q1 2025.
- SG&A expenses increased to $7.2 million in Q1 2026 from $5.7 million in Q1 2025.
Price Impact
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