STOCKHOLM, Dec. 29, 2025 — Following the guidance of the U.S. Food and Drug Administration (FDA), Diamyd Medical has aligned with the FDA to speed up the primary efficacy readout in its ongoing, crucial, registrational Phase 3 DIAGNODE-3 trial for type 1 diabetes. The readout will be advanced from 24 months to 15 months. This allows the full primary efficacy readout of the trial to take place nine months earlier than previously planned and announced. The previously disclosed interim efficacy readout, which involves around 170 participants with 15 – month data, is still on schedule for the end of March 2026 and might support an accelerated Biologics License Application (BLA) pathway, in line with FDA guidance.

“We’re extremely satisfied with the FDA’s feedback as it offers a clear path ahead,” states Ulf Hannelius, CEO of Diamyd Medical. “The proposed alteration significantly shortens the timeline for the full primary efficacy readout in our registrational Phase 3 trial while still maintaining a comprehensive assessment of long – term efficacy. We continue to focus on the upcoming interim efficacy readout in March 2026, which is progressing as planned and is the next key factor in our efforts to bring this therapy to type 1 diabetes patients.”

The co – primary efficacy endpoints of the trial, namely the C – peptide area under the curve (AUC), which is a marker of endogenous insulin production, and HbA1c, a measure of blood sugar control, were initially set at 24 months. After a recent Type C meeting and in accordance with FDA guidance, the FDA has agreed to the Company’s proposal to change the time point for the primary efficacy readout to 15 months. A formal protocol amendment will be submitted for FDA review. The originally planned 24 – month assessment will be retained as a secondary endpoint to evaluate the durability of the treatment effect of Diamyd^®.

DIAGNODE – 3 is a randomized, double – blind, placebo – controlled Phase 3 trial that assesses Diamyd® in approximately 300 genetically identified individuals with Stage 3 type 1 diabetes. Diamyd^® is a precision – medicine, antigen – specific immunotherapy developed to preserve endogenous insulin production.

The FDA has given Fast Track Designation to Diamyd^® for all Stages 1 – 3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed that C – peptide is an acceptable surrogate endpoint that could support an accelerated approval pathway in the United States.

About Diamyd Medical

Diamyd Medical creates precision medicine therapies to prevent and treat type 1 diabetes. Diamyd^® is an investigational antigen – specific immunomodulatory treatment aimed at preserving endogenous insulin production, specifically for individuals carrying an HLA DR3 – DQ2 gene. The U.S. FDA has granted Diamyd^® Orphan Drug Designation and Fast Track Designation for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. It has also received Fast Track Designation for the treatment of Stages 1 and 2 (pre – symptomatic) type 1 diabetes. DIAGNODE – 3, a confirmatory Phase 3 trial with the potential for an accelerated approval pathway in the US, is currently recruiting patients with recent – onset (Stage 3) type 1 diabetes at 57 clinics in eight European countries and in the US. Significant outcomes in preserving endogenous insulin production have been previously demonstrated in a large genetically pre – defined patient group, both in a large – scale meta – analysis and in the Company’s prospective European Phase 2b trial. The DIAGNODE – 3 trial is only recruiting this patient group that has the common genotype known as HLA DR3 – DQ2, which makes up around 40 % of type 1 diabetes patients in Europe and the US. A biomanufacturing facility is being developed in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in the antigen – specific immunotherapy Diamyd^®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.

Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail:

Diamyd Medical AB (publ)
Box 7349, SE – 103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: Reg. no.: 556242 – 3797 Website:

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