Knight Therapeutics Submits NIKTIMVO for Approval 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.

Knight Therapeutics, a leading Canadian pharmaceutical company, has made a significant announcement regarding the regulatory submission of their product NIKTIMVO (Axatilimab) in Brazil. This development comes as part of the company's strategy to expand its reach and provide accessible therapeutic options to patients in the region.

NIKTIMVO is positioned as a groundbreaking treatment, specifically aimed at addressing a range of medical conditions that require innovative therapeutic solutions. The regulatory submission marks a critical step in the process of bringing this beneficial treatment to the Brazilian market, aligning with Knight Therapeutics' commitment to enhancing patient care through advanced pharmaceuticals.

The submission process to Brazilian health authorities is rigorous, aiming to ensure that all medications approved for market are safe, effective, and of high quality. This process involves an extensive review of clinical data, product efficacy, and safety profiles. Knight Therapeutics has been proactive in gathering the necessary data to support this submission, showcasing extensive research and development efforts.

Brazil represents a vital market for pharmaceutical innovations, characterized by a large population and a growing demand for modern treatments. By introducing NIKTIMVO, Knight Therapeutics aims to meet the needs of healthcare providers and patients alike, especially in therapeutic areas where treatment options may be limited.

Moreover, Knight Therapeutics' submission for NIKTIMVO reflects their continual dedication to addressing healthcare challenges in Latin America. The company is focused not only on profit but also on patient outcomes and the accessibility of necessary treatments in underserved regions.

The success of this regulatory submission could pave the way for further collaborations between Knight Therapeutics and local healthcare systems, leading to improved health outcomes for patients in Brazil. As the review process unfolds, stakeholders will be closely monitoring the progress and potential implications for the healthcare landscape in the region.