Viridian Anti-IGF-1R Antibody Succeeds Phase 3, FDA Filing Imminent Viridian's antibody met primary endpoint. Second Phase 3 trial successful. FDA submission planned next year. Amgen's Tepezza faces new rival. Viridian Therapeutics announced its Anti-IGF-1R antibody achieved its primary endpoint in a second Phase 3 trial. This pivotal success follows a previous positive Phase 3 readout. The trial evaluated proptosis reduction, a key metric for Thyroid Eye Disease (TED). This robust data package now positions Viridian for regulatory submission. This positive outcome clears the path for a New Drug Application (NDA) with the FDA. Viridian plans to submit the NDA in early 2027. The FDA will review the comprehensive data package under 21 CFR Part 314. No specific EMA action for this drug is currently recorded in the BrunoSan database. This development impacts the competitive landscape. Viridian's antibody directly challenges Amgen's blockbuster Tepezza (teprotumumab). It also positions Viridian against potential future entrants like RVL-1201. This new option could offer patients a competitive alternative by Q4 2027.