Nanexa AB (publ) announced that in the ongoing review process of the clinical trial application for the phase I study with NEX-22, additional supplements have been requested from the German Medicines Agency, which in the new European regulatory process takes more time than expected. Nanexa is developing NEX-22, a one-month product of the GLP-1 substance liraglutide, for the treatment of type 2 diabetes. In December 2023, the company submitted a clinical trial application for a first phase I study with N EX-22 and was informed during the first quarter of 2024 that certain supplements and clarifications of the application were requested, and most of these clarifications were also accepted by the authority during the first quarter.

A few remaining supplements were handled quickly by Nanexa, but with the new European system for reviewing clinical trials, a new submission of the application was required, which in itself has delayed the process. Nanexa has now received some additional questions from the authority based on the new review of the application. The company sees no difficulty in answering these, but the application will not be approved in April with the current timeline.