Diamyd Medical to pursue accelerated approval pathway for Type 1 Diabetes precision medicine
Diamyd Medical will pursue an accelerated approval pathway in the U.S. for its antigen-specific immunotherapy, Diamyd[® ](rhGAD65/alum), aimed at preserving endogenous insulin production in patients with Stage 3 Type 1 Diabetes. An earlier interim study readout from the ongoing Phase 3 trial, DIAGNODE-3, is planned to serve as the basis for a Biologics License Application (BLA) under the accelerated approval pathway. Results from the interim readout are expected around March 2026.“We are committed to working at full speed with our partners and in close dialogue with the FDA to seize this