09:21 AM EDT, 09/29/2025 (MT Newswires) -- Novo Nordisk ( NVO ) said Monday it has submitted a biologics license application to the US Food and Drug Administration for Mim8, or denecimig, to treat patients with hemophilia A.

The company said Mim8 would come in a single-use, prefilled disposable pen injector with dosing options of once monthly, once every two weeks, or once every week.

The FDA filing is based on the results of the Frontier clinical program that assessed the efficacy and safety of denecimig as a prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A, with or without inhibitors, the company said.

Shares of Novo Nordisk ( NVO ) were down more than 3% in recent premarket activity Monday.