Bioxcel Therapeutics Soars 34.67% on FDA sNDA Alignment

On August 18, 2025, Bioxcel Therapeutics surged 34.67% in pre-market trading, marking a significant rise in its stock price.

Bioxcel Therapeutics has achieved a major milestone with the FDA, aligning on the sNDA package to expand the IGALMI label for at-home use. This alignment, confirmed through written responses received on August 14, 2025, sets the stage for the sNDA submission, which is on track for the first quarter of 2026. This positive development has bolstered investor confidence, contributing to the stock's surge.

The FDA's alignment on the content and format requirements for the sNDA submission for BXCL501 further solidifies Bioxcel Therapeutics' position. This regulatory progress is crucial for the company's strategic plans, as it paves the way for potential label expansions and market opportunities.

Bioxcel Therapeutics' positive interactions with the FDA have not only influenced its stock performance but also highlighted the company's commitment to advancing its pipeline. The alignment on the sNDA package for IGALMI and BXCL501 reflects the FDA's confidence in Bioxcel Therapeutics' regulatory strategy and clinical data, positioning the company for future growth and innovation.