Diamyd Medical is making strides toward potential market approval for its Diamyd® therapy, an antigen-specific immunotherapy for Type 1 Diabetes. The company's Annual Report for 2023/2024 reflects positive feedback from the U.S. Food and Drug Administration (FDA) regarding the possibility of earlier market approval. This progress is underscored by the FDA granting Fast Track designation to Diamyd® for the treatment of Stage 1, 2, and 3 Type 1 Diabetes.
Positive Clinical and Regulatory Milestones
The past year has been marked by significant achievements, including a successful interim analysis of the Phase 3 DIAGNODE-3 trial. Ulf Hannelius, CEO of Diamyd Medical, stated, "This strong momentum means that we are now entering an intensive period of preparation for potential market approval. We are proud to lead the development of antigen-specific immunotherapy for Type 1-Diabetes and work tirelessly towards our goal of making Diamyd® available to patients worldwide."
Financial Position and Future Outlook
As of the end of the financial year, Diamyd Medical reported SEK 132.4 million in cash and cash equivalents, which further increased to SEK 157.5 million in September and October through milestone payments and warrant redemptions. The company anticipates increased activities related to the potential market approval of Diamyd®, which may necessitate additional financing in the coming year.
About Diamyd® and DIAGNODE-3 Trial
Diamyd® is designed to preserve endogenous insulin production in individuals with Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). The ongoing DIAGNODE-3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes across 60 clinics in Europe and the US. Prior studies have demonstrated significant results in a genetically predefined patient group, including a Phase 2b trial where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes.
Diamyd Medical is also developing Remygen®, a GABA-based investigational drug, for metabolic diseases and holds significant shares in NextCell Pharma AB and MainlyAI AB.
