C-peptide

Diamyd® immunotherapy shows significant C-peptide preservation in Type 1 Diabetes patients with HLA DR3-DQ2, supporting potential for precision medicine to delay disease progression.

Diamyd Medical partners with INNODIA to boost Type 1 Diabetes awareness and patient recruitment for the DIAGNODE-3 trial, aiming for an accelerated Biologics Licensing Application in the U.S.

Diamyd Medical aims for Accelerated Market Approval for its precision medicine for autoimmune diabetes. Key events include positive FDA feedback on potential Accelerated Approval for Diamyd® in Type 1 Diabetes, securing second U.S. FDA Fast Track designation, and positive interim analysis results for Phase 3 Trial DIAGNODE-3. The company plans to pursue an accelerated approval pathway for Diamyd®, with an interim readout expected in March 2026.

Diamyd Medical plans to pursue accelerated approval in the U.S. for its Diamyd® (rhGAD65/alum) immunotherapy, targeting Stage 3 Type 1 Diabetes. The decision is based on an interim readout from the ongoing Phase 3 DIAGNODE-3 trial, expected in March 2026, which will serve as the basis for a Biologics License Application (BLA). The FDA has acknowledged the potential for accelerated approval based on C-peptide levels, a measure of endogenous insulin production.