Diamyd Medical’s pivotal Phase 3 Type 1 Diabetes trial clears second-to-last safety review ahead of early readout in March 2026
The independent Data Safety Monitoring Board (DSMB) has completed its fifth scheduled safety review of Diamyd Medical’s registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd[®]. The review identified no safety concerns and resulted in a recommendation to continue the trial as planned.DIAGNODE-3 is conducted under Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA), with an agreement in place that an early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (