BioXcel Therapeutics announces pre-sNDA meeting responses from FDA

BioXcel Therapeutics (BTAI) announced that it has received positive pre-sNDA meeting responses from the U.S. Food and Drug Administration, FDA. Based on the FDA’s feedback, the Company believes that the planned sNDA regulatory package will be sufficient to support the sNDA submission, which remains on track for the first quarter of 2026. The primary purpose of the planned meeting was to gain alignment with the FDA regarding the content and format of the Company’s planned supplemental New Drug Application submission for the at-home use of BXCL501, including the clinical, nonclinical, and chemistry and manufacturing and controls requirements. The Company concludes that the objectives of the pre-sNDA meeting have been accomplished based on the FDA’s written responses and has determined that the meeting, originally scheduled for August 20, 2025, is no longer required. The pre-sNDA preliminary meeting comments received from FDA on August 14, 2025, will serve as the official record. Acceptance of the sNDA will be subject to the FDA’s review of the complete filing.