Clinical-stage diabetes company Diamyd Medical (FNG:DMYD-B) announced on Monday that it plans to seek accelerated approval in the US for its immunotherapy, Diamyd (rhGAD65/alum), aimed at preserving insulin production in Stage 3 Type 1 Diabetes patients.

The application will be based on interim results from the Phase 3 DIAGNODE-3 trial, expected in March 2026. The US Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd and confirmed the potential for accelerated approval based on C-peptide levels, a surrogate endpoint for insulin production.

Diamyd Medical will analyze data from 170 participants with 15-month assessments for the Biologics License Application (BLA). The ongoing DIAGNODE-3 trial will continue to monitor patients until the 24-month assessment. Full recruitment of 330 patients across Europe and the US is expected by the end of 2025. Diamyd targets a subgroup of patients with the HLA DR3-DQ2 genotype, shown to respond in earlier studies.