Bioxcel Therapeutics shares surge 15.34% after-hours after announcing sNDA submission for at-home IGALMI® use in bipolar/schizophrenia agitation treatment.

Bioxcel Therapeutics surged 15.34% in after-hours trading following the announcement that it plans to submit a supplemental New Drug Application (sNDA) this month to the FDA for at-home use of its drug IGALMI® in treating acute agitation linked to bipolar disorders or schizophrenia. The company emphasized that this expansion of IGALMI®’s indication could fill an unmet medical need, as no FDA-approved at-home treatments currently exist for this use. With the CEO stating potential approval as early as 2026, the news signaled regulatory progress and market expansion prospects, driving investor optimism. The sNDA filing aligns with the company’s AI-driven drug development strategy and positions IGALMI® for a broader patient population, reinforcing positive sentiment in after-hours trading.