United States — Food and Drug Administration & GT Biopharma

United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase in February 2026, indicating potential future market expansion for the drug in the US.

GT Biopharma: GT Biopharma announced positive topline results from its European Post Authorization Efficacy Study for Imlifidase, fulfilling a key requirement for full marketing authorization and boosting its product's market potential.

United States — Food and Drug Administration: The FDA's acceptance of the BLA and PDUFA date of December 19, 2026, are key upcoming regulatory milestones for GT Biopharma in the US market.

GT Biopharma: GT Biopharma achieved a commercial milestone with the first commercial use of Idefirix in Australia, supporting its growth strategy. The company continues to advance regulatory processes, including the FDA BLA review.

United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase, setting a PDUFA action date for December 19, 2026.

GT Biopharma: GT Biopharma announced that results from its US Phase 3 ConfIdeS trial in kidney transplantation have been accepted for an oral presentation at the American Transplant Congress, which is a positive development for the company's imlifidase product.

United States — Food and Drug Administration: United States — Food and Drug Administration has engaged with the CannEpil program through the pre-IND process and assigned an Investigational New Drug (IND) number, laying the foundation for future U.S. clinical development.

GT Biopharma: GT Biopharma licensed its CannEpil therapeutic to Splash Beverage Group globally. GT Biopharma will receive a 15% royalty on net revenue from worldwide sales of CannEpil and had approximately $5 million of its indebtedness forgiven by Mercer Street Global Opportunity Fund.

United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for imlifidase in the US, indicating future market potential outside the current deal.

GT Biopharma: GT Biopharma>>> divested the European and MENA rights to Imlifidase for 115 million euros, allowing it to focus on other markets and receive significant payments.