Swedish biotechnology company Diamyd Medical AB (Nasdaq First North Growth Market:DMYD-B) said on Monday that it has reached alignment with the US Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes from 24 to 15 months based on FDA guidance.

This move allows the trial's full primary efficacy readout to occur nine months earlier than the planned timeline. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA guidance.

DIAGNODE-3 is a randomised, double-blind, placebo-controlled Phase 3 trial evaluating Diamyd in approximately 300 genetically defined individuals with Stage 3 type 1 diabetes. Diamyd is a precision-medicine, antigen-specific immunotherapy designed to preserve endogenous insulin production.

The FDA has granted Fast Track Designation for Diamyd across Stages 1-3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed C-peptide as an acceptable surrogate endpoint that may support an accelerated approval pathway in the United States.