Diamyd Secures U.S. Funding for Advance Phase III
Swedish company Diamyd Medical has secured significant new funding from leading U.S. -based healthcare investors while reaching a key milestone in its clinical development program for type 1 diabetes.
The company announced equity financing agreements that include an initial USD 25 million to be received shortly, with additional funding potential of approximately USD 135 million before summer, conditional upon full exercise of warrants and before transaction costs. This consists of USD 100 million through warrants from new investors and USD 35 million through warrants from the existing TO5 programme.
The financing brings in a group of prominent U.S. sector specialist investors, including Perceptive Advisors, Vestal Point Capital, RA Capital Management, Vivo Capital, Caligan Partners, Seven Fleet Capital, ADAR1 Capital Management, Great Point Partners, LLC, Logos Capital, and Sphera Healthcare. These investors focus on clinical-stage biotech companies with strong scientific validation, clear catalysts, and commercial potential. Sweden’s life sciences sector is recognized for high-quality research, innovative pipelines, and comparatively attractive valuations.
According to CEO Ulf Hannelius, the investment strengthens the company’s financial position and aligns it more closely with the U.S. market, which will be central to its future strategy. The proceeds are intended to support the completion of Diamyd Medical’s ongoing Phase III trial, as well as preparations for potential commercialization and continued pipeline development.
In parallel, Diamyd Medical confirmed that its pivotal Phase III DIAGNODE-3 trial has now been fully enrolled. The study, evaluating the investigational immunotherapy candidate retogatein (rhGAD65), includes 321 patients across 57 clinical sites in Europe and the United States.
Results from a scheduled interim analysis of the trial are expected to be announced on March 27, 2026, following a review by the Data Safety Monitoring Board (DSMB). Retogatein is a precision medicine therapy designed to preserve insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. The therapy has received both Orphan Drug and Fast Track designations in the U.S., reflecting its potential to address a significant unmet medical need. With financing secured and enrollment completed, Diamyd Medical enters a critical phase in its development journey, positioning the company for upcoming clinical results and the next steps toward commercialization.
