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 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.