Diamyd Medical, a Sweden-based company that develops precision medicine therapies for Type 1 Diabetes, announced on Monday that the US Food and Drug Administration (FDA) has withdrawn the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, assessing the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.

Subsequent to the decision from the FDA, DIAGNODE-3 is approved to commence in the United States.

The FDA issued a partial clinical hold on the trial in September 2021, halting its commencement in the US. The company is to immediately resume the process of interacting with clinical sites and institutional review boards with the intention of including US clinical sites in the trial. The trial has been approved and is actively hiring patients in eight European countries.