Knight Therapeutics Inc. (TSX: GUD) announced on October 6, 2026, that Brazil's health regulator ANVISA has granted accelerated regulatory approval for NIKTIMVO® (axatilimab) under its rare disease pathway. The approval covers treatment of chronic graft-versus-host disease (cGVHD) following failure of at least two prior lines of systemic therapy in adult and paediatric patients aged six and older weighing at least 40 kg. The milestone expands Knight's commercial footprint in Latin America and reflects the company's growing oncology and rare disease portfolio in the region.

Key Points

  • Knight Therapeutics Inc. (TSX: GUD) is a Montreal-based pan-American pharmaceutical company
  • ANVISA granted accelerated approval for NIKTIMVO® (axatilimab) in Brazil under the rare disease regulatory pathway on October 5, 2026
  • Brazil records 1,400 to 1,800 allogeneic transplants annually; cGVHD affects 30 to 70 per cent of recipients globally
  • Investors may be watching how Knight progresses toward commercialisation of NIKTIMVO® across its Latin American markets

ANVISA Accelerated Approval Under Brazil's Rare Disease Pathway

ANVISA approved NIKTIMVO® on October 5, 2026, through its expedited rare disease regulatory route. The approval applies to adult and paediatric patients aged six and older weighing at least 40 kg who have exhausted at least two previous systemic treatment lines for cGVHD. The release states that NIKTIMVO® is a first-in-class antibody that blocks the colony-stimulating factor-1 receptor (CSF-1R), targeting underlying drivers of cGVHD. The drug was previously approved in the United States for the same indication.

Knight and Incyte's Expanded Latin American Distribution Agreement

Knight's rights to distribute NIKTIMVO® in Latin America stem from an expanded agreement with Incyte Corporation (NASDAQ: INCY) signed in August 2025. Under the arrangement, Incyte is responsible for development, manufacturing, and supply, while Knight holds responsibility for obtaining regional regulatory approvals and commercialising the products. The agreement added NIKTIMVO® and ZYNYZ® (retifanlimab) to an earlier 2021 deal that already covered MINJUVI® (tafasitamab) and PEMAZYRE® (pemigatinib) across Latin American markets.

Chronic GvHD Burden in Brazil and the Patient Population Addressed

cGVHD is a serious late complication of allogeneic stem cell transplantation in which donor immune cells attack recipient tissue. The release states that Brazil records between 1,400 and 1,800 allogeneic transplants each year, and data cited from the Brazilian hematopoietic stem cell transplant registry places the two-year cumulative incidence of cGVHD at 29.5 per cent. Globally, cGVHD affects between 30 and 70 per cent of transplant recipients. The condition can involve multiple organs and cause irreversible fibrotic damage, significantly affecting patient quality of life and survival.