Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY APPROVAL OF TAVALISSEtrademark IN BRAZIL

Knight Therapeutics Inc.'s Brazilian affiliate, United Medical Ltda., has received regulatory approval from ANVISA for Tavalisse (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

"Fostamatinib is an effective and well-tolerated new treatment option that addresses an unmet need in Brazil for ITP patients who have had an insufficient response to their treatment and remain at risk of bleeding," said Dr. Ana Clara Kneese Nascimento, professor at the faculty of medical sciences of Santa Casa de Sao Paulo and hematologist responsible for the Platelet Outpatient Clinic of Santa Casa de Sao Paulo.

"We are excited to receive the approval of Tavalisse in Brazil. The approval of Tavalisse not only provides a new treatment option with a different mechanism of action for adult patients with chronic ITP but also demonstrates Knight's ability to address the complex regulatory requirements of the health agencies across all our countries," said Samira Sakhia, president and chief executive officer of Knight Therapeutics. "We expect the launch of Tavalisse in Brazil in the second half of 2026."

Knight announced its agreement with Rigel Pharmaceuticals Inc. in May, 2022, securing exclusive rights to commercialize fostamatinib in Latin America. In 2023, Knight submitted fostamatinib for regulatory approval in Colombia and in 2025 in Argentina and Paraguay. In December, 2024, Knight also announced the regulatory approval for fostamatinib in Mexico and expects to launch commercially in the first half of 2026.

About Tavalisse (fostamatinib disodium hexahydrate)

Fostamatinib is an orally administered spleen tyrosine kinase (SYK) inhibitor. It is currently available in the United States as Tavalisse (100-milligram and 150-milligram tablets) and in Europe under the brand name Tavlesse for the treatment of adult chronic ITP with an insufficient response to a previous treatment.

About ITP

In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP in Brazil include steroids, blood platelet production boosters like thrombopoietin receptor agonists (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About FIT trial

The approval was supported by two parallel, randomized, double-blind, placebo-controlled phase 3 trials, FIT-1 and FIT-2 (n equals 150), and the open-label FIT-3 extension. Patients received fostamatinib 100 milligrams twice daily for 24 weeks with an optional increase to 150 mg twice daily after one month.

Across FIT-1 and FIT-2, the primary end-point-stable platelet response (greater than or equal to 50 multiplied by 10 to the power of nine/litre at greater than or equal to four of six assessments during weeks 14 to 24, without rescue therapy) -- was achieved by 18 per cent of patients on fostamatinib versus 2 per cent on placebo (p equals .0003). Overall responses (defined retrospectively as greater than or equal to one platelet count greater than or equal to 50,000/muL within the first 12 weeks on treatment) occurred in 43 per cent of patients on fostamatinib vs. 14 per cent on placebo (p equals .0006). In FIT-3, 23 per cent of patients newly treated with fostamatinib (treated with placebo in the prior studies) achieved a stable response. Among the subjects who achieved stable response in FIT-1, FIT-2 and FIT-3 trials, 18 subjects maintained the platelet count of at least 50 by 109/L for 12 months or longer.

The most common adverse reactions (greater than or equal to 5 per cent) included diarrhea, hypertension, nausea, dizziness, elevated ALT/AST, respiratory infection, rash, abdominal pain, fatigue, chest pain and neutropenia. Serious adverse drug reactions reported in 1 per cent of patients included febrile neutropenia, diarrhea, pneumonia and hypertensive crisis.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a 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' shares trade on Toronto Stock Exchange under the symbol GUD.

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