European Union — European Medicines Agency & GT Biopharma

European Union — European Medicines Agency: The European Union — European Medicines Agency conditionally approved Imlifidase and requested the PAES study, which has now been successfully completed, paving the way for a full marketing authorization application.

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.

European Union — European Medicines Agency: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.

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.

European Union — European Medicines Agency: The European Union — European Medicines Agency reviewed IDEFIRIX as part of its PRIority Medicines program, supporting its conditional marketing approval in Europe.

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.

European Union — European Medicines Agency: The EMA's prior conditional approval and PRIME designation support Idefirix's regulatory standing in Europe, though not directly impacted by this event.

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.