FDA Accepts IGALMI At-Home sNDA with Nov. 14 PDUFA Date as BioXcel Weighs Strategic Options
BTAI•FDA accepted sNDA for IGALMI at-home treatment of acute agitation in bipolar disorder and schizophrenia, setting a PDUFA date of November 14, 2026. BioXcel reported Q1 revenue of $206,000, a net loss of $12.7 million and $17.2 million in cash while engaging advisors to explore strategic options for IGALMI.
1. FDA Accepts IGALMI At-Home sNDA
BioXcel announced that the FDA has accepted its supplemental NDA to expand IGALMI for at-home acute agitation treatment in bipolar disorder and schizophrenia, setting a PDUFA target action date of November 14, 2026.
2. Strategic Options Engagement
BioXcel engaged MTS Health Partners to evaluate strategic options—ranging from sale, merger, collaboration, to licensing—to maximize shareholder value and advance IGALMI’s commercial and development plans, with no definitive transaction selected or timeline set.
3. Q1 Financial Results
In Q1 2026, BioXcel reported $206,000 in IGALMI net revenue, a net loss of $12.7 million, R&D expenses of $3.0 million, SG&A of $7.2 million, and $17.2 million in cash and restricted cash as of March 31, 2026.
