Knight Therapeutics Inc. (TSX: GUD) announced on October 6, 2026 that it has received expedited regulatory approval from Brazil's ANVISA for NIKTIMVO® (axatilimab), a first-in-class treatment for chronic graft-versus-host disease (cGVHD). The approval covers adult and pediatric patients aged 6 years and older weighing at least 40 kg who have failed at least two prior lines of systemic therapy. The milestone advances Knight's commercialisation strategy across Latin America and broadens its partnership with Incyte Corporation (NASDAQ: INCY).

Key Points

  • Knight Therapeutics Inc. (TSX: GUD) is a Montreal-based pan-American pharmaceutical company
  • ANVISA granted expedited approval of NIKTIMVO® (axatilimab) in Brazil under its rare disease pathway on October 5, 2026
  • Brazil records approximately 1,400–1,800 allogeneic transplants annually, with a 2-year cumulative cGVHD incidence of 29.5% per national registry data
  • Investors may be watching how quickly Knight can commercialise NIKTIMVO® across its Latin American subsidiaries

ANVISA Rare Disease Pathway Clears NIKTIMVO® for cGVHD Patients in Brazil

Knight Therapeutics announced that ANVISA approved NIKTIMVO® through its expedited rare disease pathway, with the regulatory decision dated October 5, 2026. The approval targets patients with chronic graft-versus-host disease who have exhausted at least two prior lines of systemic therapy — a population with limited treatment options. NIKTIMVO® works as a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, targeting what the company describes as the underlying drivers of cGVHD. The drug is already approved in the United States for the same indication in patients weighing at least 40 kg.

Expanded Incyte Partnership Underpins Knight's Latin American Oncology Portfolio

Knight's rights to distribute NIKTIMVO® in Latin America stem from an expanded agreement with Incyte signed in August 2025, which added NIKTIMVO® and ZYNYZ® (retifanlimab) to an existing supply and distribution arrangement established in September 2021 that covers MINJUVI® (tafasitamab) and PEMAZYRE® (pemigatinib). Under the amended terms, Incyte retains responsibility for development, manufacture, and supply, while Knight is responsible for regulatory approvals and commercialisation across Latin American markets. The release states that NIKTIMVO®, MINJUVI®, PEMAZYRE®, and ZYNYZ® are trademarks of Incyte.

cGVHD Disease Burden Highlights Addressable Market in Brazil

Chronic GVHD is described in the announcement as the most common late complication of allogeneic hematopoietic cell transplantation, affecting 30%–70% of recipients globally. In Brazil specifically, a national registry analysis determined a 2-year cumulative cGVHD incidence of 29.5%, with 1,400–1,800 allogeneic transplants reported annually. The condition can affect multiple organs including skin, liver, lungs, and the gastrointestinal tract, and is associated with significant mortality, morbidity, and reduced quality of life. The disclosure suggests meaningful unmet need in Brazil that Knight intends to address through NIKTIMVO®'s commercialisation. The immediate share price impact was not clear from available public information.