C-peptide

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.

Diamyd Medical announced a favorable interim analysis for its Phase 3 DIAGNODE-3 trial by an independent DSMB, recommending continuation without modifications. The trial evaluates Diamyd®'s efficacy in preserving insulin production in Type 1 Diabetes patients, with potential for accelerated FDA approval based on C-peptide levels as a surrogate endpoint.

Diamyd Medical received FDA feedback supporting Accelerated Approval for Diamyd®, targeting Stage 3 Type 1 Diabetes with HLA DR3-DQ2. C-peptide levels may serve as a surrogate endpoint, potentially expediting approval. The company is advancing discussions with the FDA for a Biologics License Application, aiming to make the therapy available sooner.