Core Viewpoint - Knight Therapeutics Inc. has submitted a marketing authorization application for NIKTIMVO (axatilimab) in Brazil for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies in patients aged 6 years and older [1] Company Developments - Knight Therapeutics expanded its agreement with Incyte for exclusive distribution rights of retifanlimab and axatilimab in Latin America, with Incyte responsible for development and supply, while Knight handles regulatory approvals and distribution [2] - NIKTIMVO received FDA approval in August 2024 for chronic GVHD treatment in patients weighing at least 40 kg after failure of two prior systemic therapies [3] - The CEO of Knight emphasized the importance of new treatment options for chronic GVHD patients, highlighting the company's commitment to improving patient access to effective therapies [4] Industry Context - Chronic GVHD is a significant complication following allogeneic stem cell transplantation, affecting 30%-70% of recipients globally, with approximately 1,400 to 1,800 allogeneic transplants reported annually in Brazil [5] - The cumulative incidence of chronic GVHD after two years is reported to be 29.5% based on recent analyses [5] - NIKTIMVO is a first-in-class CSF-1R-blocking antibody, with ongoing studies for its efficacy in combination therapies for chronic GVHD and other conditions [6][8]