Diamyd Medical Gains Significant Patent Notice for Retogatein in the U.S.

Diamyd Medical Secures Crucial Patent for Retogatein

Diamyd Medical, a pioneering force in the biotech sector, declared on February 9, 2026, that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent linked to their innovative treatment for type 1 diabetes utilizing retogatein (rhGAD65) with alum. This milestone plays a fundamental role in further enhancing Diamyd Medical's intellectual property portfolio, which is crucial for developing precision immunotherapy solutions aimed at treating type 1 diabetes.

The newly granted U.S. patent is a vital addition to an extensive patent family that already includes protections in various regions including Europe, Australia, and Japan, showcasing a robust international strategy for patent protection. As emphasized by Ulf Hannelius, the President and CEO of Diamyd Medical, securing this patent is particularly significant, since it fortifies the company’s global intellectual property for its antigen-specific immunotherapy endeavors. With a target patent expiration date set for 2035, the company aims to ensure long-term sustainability and protection for its innovative treatment solutions.

Retogatein serves a pivotal role in Diamyd Medical's strategy to induce immune tolerance. This innovative therapy is currently undergoing a Phase 3 clinical trial — DIAGNODE-3 — in patients recently diagnosed with Stage 3 type 1 diabetes. The interim efficacy results from this trial are anticipated by the end of March 2026, providing insights into the potential of retogatein in reversing the course of the disease effectively. The administration method safeguarded by this patent involves intralymphatic delivery, a technique exhibiting promise for enhancing treatment efficacy.

Furthermore, the product's classification as a biologic allows it to qualify for regulatory market exclusivity in both the U.S. and Europe, further emphasizing its potential impact. This regulatory designation, independent of patent status, reinforces Diamyd Medical's commitment to ensuring that their innovative solutions reach the market effectively and efficiently.

Retogatein has been specifically formulated to establish antigen-specific immune tolerance in patients carrying the HLA DR3-DQ2 gene, which encompasses approximately 40% of individuals afflicted by type 1 diabetes in Europe and the U.S. Notably, this treatment has also achieved both Orphan Drug Designation and Fast Track Designation from the U.S. FDA, which signifies its critical potential in the healthcare space. As clinical studies continue to yield encouraging results, the prospect of commercializing retogatein hinges on the successful outcomes of ongoing trials.

On the manufacturing front, Diamyd Medical is in the process of developing a biomanufacturing facility located in Umeå, Sweden. This facility will focus on the production of retogatein, ultimately supporting the company's great strides toward meeting growing market demands for its innovative diabetes therapies. Diamyd Medical has also secured significant investments, becoming a major stakeholder in NextCell Pharma AB and MainlyAI AB, broadening its impact across the biotechnology landscape.

As the healthcare community awaits the forthcoming results from the DIAGNODE-3 trial, which may provide critical data for putting retogatein on the path to an accelerated approval pathway, stakeholders will undoubtedly keep a close watch on Diamyd Medical's progress. With a firm foundation laid with intellectual and regulatory support, the company stands poised to make a noteworthy difference in the realm of diabetes treatment and possibly redefine the management of type 1 diabetes in the near future.