Mr. Arvind Utchanah reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY APPROVAL OF NIKTIMVO IN BRAZIL

Knight Therapeutics Inc. has received expedited regulatory approval under Anvisa's rare disease pathway for Niktimvo (axatilimab), for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients six years and older weighing at least 40 kilograms.

"For patients living with chronic graft-versus-host disease who have exhausted two prior lines of therapy, access to a new treatment option can be life-changing. Niktimvo offers a first-in-class mechanism that targets the underlying drivers of this debilitating condition, and we are proud to bring it to patients in Brazil. This approval reflects the strength of our partnership with Incyte and our shared commitment to ensuring that patients in Brazil have access to innovative therapies that can make a meaningful difference in their lives," said Samira Sakhia, president and chief executive officer of Knight Therapeutics.

In September, 2021, Knight and Incyte (Nasdaq: INCY) had entered into an exclusive supply and distribution agreement for Minjuvi (tafasitamab) and Pemazyre (pemigatinib) in Latin America. In August, 2025, Knight expanded its existing relationship with Incyte, to add exclusive rights to distribute Zynyz (retifanlimab) and Niktimvo (axatilimab) in Latin America. Under the terms of the amended agreement, Incyte is responsible for the development, manufacture and supply of such products to Knight, and Knight is responsible for seeking the necessary regulatory approvals and commercializing such products in Latin America.

About Niktimvo

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the United States 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 (88.2 pounds).

In September 2021, Syndax Pharmaceuticals, Inc. and Incyte entered into an exclusive worldwide co-development and co-commercialization licence 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 (NCT06585774) are under way. Axatilimab is also being studied in an ongoing phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo, Minjuvi, Pemazyre and Zynyz are trademarks of Incyte. All other trademarks are the property of their respective owners.

About c 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 posttransplant. 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.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, 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.

We seek Safe Harbor.