Drive and precision

Diamyd Medical is at the center of a major change in type 1 diabetes – a shift from managing the disease to influencing its progression. Our mission is clear: to restore the immune system’s balance through precision immunotherapy and help people preserve what nature intended – their endogenous insulin production.

Our investigational drug Diamyd^® (rhGAD65/alum) represents a new generation of treatment methods for autoimmune diseases. It is based on the principles of precision medicine and immune tolerance, and targets individuals with specific genetic profiles linked to immunoreactivity to the GAD antigen. By re-training the immune system to tolerate instead of attack, Diamyd^® aims to preserve the natural ability to produce insulin – an ability that is crucial for stable glycemic control, fewer complications and a better quality of life for people living with type 1 diabetes.

Developments in this field have never had greater momentum, supported by a regulatory climate that increasingly favors disease-modifying therapies for type 1 diabetes. With the FDA Fast Track Designation for Diamyd^®, the recognition of C-peptide as a surrogate marker for accelerated approval, and FDA approval of the disease-modifying drug TZIELD^® (teplizumab), there is now clear regulatory consensus and growing recognition among payers of the value of treatments aimed at preserving the body’s endogenous insulin production.

Diamyd Medical is leading the next wave of innovation – with Diamyd^® as the most clinically advanced antigen-specific immunotherapy in development for type 1 diabetes. By combining genetic precision, a favorable safety profile and clinical applicability, Diamyd^® is helping to define a new class of targeted therapies that address the underlying cause of disease.

Looking ahead, we see that 2026 and beyond will be an eventful period for Diamyd Medical. The early Phase 3 analysis from DIAGNODE-3 will be an important milestone to assess Diamyd^®’s potential to preserve insulin production in people newly diagnosed with the disease. It also offers us early evidence of our precision medicine platform technology. The focus going forward is on our manufacturing capacity and regulatory preparedness, broadening our platform for precision immunotherapy and preparing for commercialization – all part of our long-term vision to detect and treat type 1 diabetes earlier, and potentially reverse the disease progression before insulin dependence develops.

We move forward with focus, responsibility and conviction: to make immunological tolerance a clinical reality, to bring real benefit to people with type 1 diabetes and to confirm what we have always believed –  “There’s no insulin like your own.”

Stockholm, November 12, 2025
Ulf Hannelius, President and CEO