Diamyd Medical accelerates primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance

Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes from 24 to 15 months, per FDA guidance, enabling the full primary efficacy readout of the trial to occur nine months earlier than previously planned and communicated. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA