C-peptide

Diamyd Medical announced a positive FDA meeting, aligning on key components for an accelerated approval pathway for Diamyd® (rhGAD65/alum), potentially allowing earlier market availability. The early readout for the Phase 3 DIAGNODE-3 trial is planned for March 2026, with efficacy data based on C-peptide levels.

180 patients recruited in DIAGNODE-3 trial, exceeding target for early readout in March 2026, supporting potential accelerated BLA. Diamyd Medical remains committed to transforming Type 1 Diabetes care through precision medicine.

Diamyd Medical AB announced 180 patients recruited in Phase 3 trial DIAGNODE-3, exceeding the target for early readout in March 2026, supporting a potential accelerated Biologics License Application (BLA). The trial aims to evaluate Diamyd®, an antigen-specific immunotherapy for Type 1 Diabetes, focusing on beta cell function preservation in a genetic subgroup. Recruitment continues for comprehensive data collection from 330 patients.

Diamyd® treatment shows significant C-peptide preservation improvements across trials, supporting potential for precision medicine in Type 1 Diabetes, with a benign safety profile positioning it as a best-in-class immunotherapy.

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.