BioXcel Therapeutics, Inc. (BTAI) Monday said it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the planned sNDA submission for IGALMI. Following the news, the company's shares were more than 30% up in pre-market.
The FDA feedback confirmed agreement on the content and format for the company's sNDA submission to expand the IGALMI label for the At-Home setting. BioXcel's IGALMI is currently approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.
The company plans to submit sNDA for IGALMI in the first quarter of 2026.
BioXcel stock had closed at $5.48, up 15.37% on Friday. Ithas traded in the range of $1.17 - $13.36 in the last 1 year.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.