MONTREAL, Canada — February 18, 2026 — Leads & Copy — Knight Therapeutics Inc. (TSX: GUD) announced its Brazilian affiliate, United Medical Ltda., has applied for marketing authorization from ANVISA, the Brazilian health regulatory agency, for NIKTIMVO® (axatilimab). The drug is intended for chronic graft-versus-host disease (GVHD) treatment after at least two prior systemic therapies have failed in adult and pediatric patients 6 years and older.
Knight expanded its agreement with Incyte on August 4, 2025, gaining exclusive rights to distribute retifanlimab (ZYNYZ® in the U.S. and Europe) and axatilimab (NIKTIMVO® in the U.S.) in Latin America. Incyte will handle development, manufacture, and supply, while Knight will manage regulatory approvals and distribution in Latin America.
In September 2021, Knight and Incyte entered a supply and distribution agreement for tafasitamab (MONJUVI® in the U.S.) and pemigatinib (PEMAZYRE® in the U.S.) in Latin America.
NIKTIMVO® received FDA approval in August 2024 for treating chronic GVHD after at least two prior systemic therapies failed in adult and pediatric patients weighing at least 40 kg.
Knight Therapeutics Inc. President and CEO Samira Sakhia said that every new treatment option can mean hope for a better quality of life for patients living with chronic graft-versus-host disease. Sakhia added that the submission of axatilimab in Brazil brings the company closer to making that hope a reality. She added that this milestone reflects the strength of the company’s partnership with Incyte and their shared dedication to improving lives across Latin America.
Chronic GVHD is a complication of allogeneic stem cell transplantation where donor immune cells attack the recipient’s tissues, often within the first year post-transplant. It involves autoimmunity, immunodeficiency, multiple organs, irreversible fibrotic manifestations, and systemic toxicities, leading to health consequences such as mortality and decreased quality of life.
Brazil reports approximately 1400 – 1800 allogeneic transplants annually. Chronic GVHD affects 30%-70% of recipients, globally. A recent analysis determined the 2-year cumulative incidence of chronic GVHD to be 29.5%.
NIKTIMVO® (axatilimab) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for chronic GVHD treatment in the U.S. after failure of at least two prior systemic therapies in adult and pediatric patients weighing at least 40 kg. Its efficacy and safety were evaluated in the AGAVE-201 phase 2 clinical trial.
Syndax licensed axatilimab from UCB in 2016. In September 2021, Syndax and Incyte entered a co-development and co-commercialization license agreement for axatilimab in chronic GVHD and future indications.
Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 trial with ruxolitinib (NCT06388564) and a Phase 3 trial with steroids. It is also in a Phase 2 trial for idiopathic pulmonary fibrosis (NCT06132256).
ZYNYZ, MONJUVI, and PEMAZYRE are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
Knight Therapeutics Inc., based in Montreal, Canada, acquires or in-licenses and commercializes pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.’s shares trade on TSX under the symbol GUD.
Source: Knight Therapeutics Inc.
