Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting

Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration (FDA) held in December 2024. The meeting focused on refining study protocol and analysis strategies for Diamyd[®] (rhGAD65/alum) in preparation for Accelerated Approval of the antigen-specific immunotherapy targeting Stage 3 Type 1 Diabetes. The final minutes from the Type C meeting confirm alignment on critical development milestones and the statistical plan, setting the stage for an expedited review pathway.As previously announced on