Knight Therapeutics Announces Regulatory Submission of NIKTIMVO® (Axatilimab) in Brazil

MONTREAL, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for NIKTIMVO^® (axatilimab) for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years and older.

On August 4, 2025, Knight announced that it expanded its existing relationship and amended its agreement with Incyte for the exclusive rights to distribute retifanlimab (commercialized as ZYNYZ^® (retifanlimab) in the United States and Europe) and axatilimab (commercialized as NIKTIMVO^® (axatilimab-csfr) in the United States) in Latin America. Under the terms of the amended agreement, Incyte will be responsible for the development, manufacture and supply to Knight of retifanlimab and axatilimab, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America. Knight and Incyte had entered into an exclusive supply and distribution agreement for tafasitamab (commercialized as MONJUVI^® (tafasitamab-cxix) in the United States) and pemigatinib (commercialized as PEMAZYRE^® in the United States) in Latin America in September 2021.

NIKTIMVO^® received approval from the U.S. Food and Drug Administration in August 2024 for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. ¹

“For patients living with chronic graft-versus-host disease, every new treatment option can mean hope for a better quality of life”, said Samira Sakhia, President and Chief Executive Officer, Knight Therapeutics Inc. “The submission of axatilimab in Brazil brings us closer to making that hope a reality. At Knight, our mission goes beyond expanding our portfolio—we are committed to ensuring that patients and their families have access to therapies that truly make a difference. This milestone reflects the strength of our partnership with Incyte and our shared dedication to improving lives across Latin America.”

About Chronic Graft-Versus-Host Disease (GVHD)

Chronic GVHD is a serious complication of allogeneic stem cell transplantation in which the donor's immune cells attack the recipient’s tissues, often occurring during the first-year post-transplant.² Chronic GVHD involves features of autoimmunity and immunodeficiency, multiple organs (such as the skin, liver, lungs, and gastrointestinal tract), irreversible fibrotic manifestations, and systemic toxicities complicated by the use of immunosuppressants which all contribute to devastating health consequences such as mortality, morbidity, and decreased quality of life in patients.³ There are approximately 1400 – 1800 reported allogeneic transplants in Brazil every year.⁴ Chronic GVHD is the most common late complication after allogeneic hematopoietic cell transplantation affecting 30%-70% of recipients, globally.³ Based on a recent analysis by the Brazilian National hematopoietic stem cell transplantation (HSCT) Registry, in collaboration with Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO), Center for International Blood and Marrow Transplant Research (CIBMTR), and Hematopoietic Cell Transplantation Brazilian Registry (HCTBR), the 2-year cumulative incidence chronic GVHD was determined to be 29.5%.⁵

About NIKTIMVO^® (axatilimab)

NIKTIMVO^® (axatilimab) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg .¹ The efficacy and safety for this indication were evaluated in the AGAVE-201 phase 2 clinical trial, a randomized, open-label, multicenter study.

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD; a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

ZYNYZ, MONJUVI, PEMAZYRE and NIKTIMVO are registered trademarks of Incyte. All other trademarks are the property of their respective owners.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing 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. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

1. Incyte Corporation. NIKTIMVO (axatilimab-csfr) injection, for intravenous use: Full prescribing information. Retrieved July 24, 2025, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761411s000lbl.pdf.
2. Jagasia, Madan et al. “Incidence and outcome of chronic graft-versus-host disease using National Institutes of Health consensus criteria.” Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation vol. 13,10 (2007): 1207-15. doi:10.1016/j.bbmt.2007.07.001
3. Kitko, Carrie L et al. “Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 41,10 (2023): 1864-1875. doi:10.1200/JCO.22.00958
4. Associação Brasileira de Transplante de Órgãos. (2024). Registro Brasileiro de Transplantes (RBT): Dados numéricos da doação de órgãos e transplantes realizados por estado e instituição no período: janeiro/setembro 2024 (Ano XXV, nº 3) [Report]. Retrieved July 25, 2025, from https://site.abto.org.br/wp-content/uploads/2024/11/RBT2024-3t-abto-populacao.pdf
5. Simione, Anderson Joao, et al. “Hematopoietic Cell Transplantation in Brazil: A National Benchmarking Study Focused on the Foundation for the Accreditation of Cellular Therapy (FACT) Performance Indicators.” Journal of Bone Marrow Transplantation and Cellular Therapy (JBMTCT), vol. 6, no. 1, 2025, pp. 1–13. doi: 10.46765/2675-374X.2025V6N1P270.
   

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.