Knight Therapeutics Announces Launch of TAVALISSE® in Mexico

MONTREAL, May 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ( "Knight ") a pan-American (ex-US) pharmaceutical company, announced today the launch of TAVALISSE^® (fostamatinib disodium hexahydrate) in Mexico, for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.¹

“Managing chronic ITP remains challenging, as patients often respond sub-optimally to available therapies and many continue to face a persistent risk of bleeding despite multiple treatment attempts. The introduction of fostamatinib in Mexico provides physicians with an important new therapeutic option, supported by solid clinical evidence and a novel mechanism of action. Its availability represents meaningful progress for patients who have not achieved adequate platelet responses with existing treatments, offering renewed confidence in our ability to tailor care to individual disease needs,” said Dr. Luis Meillón, Hematologist & President of SOMETH (Mexican Society of Thrombosis & Hemostasia).

“The launch of TAVALISSE^® in Mexico represents an important milestone in our mission to transform lives by expanding access to innovative therapies for patients across Latin America,” said Samira Sakhia, President and CEO of Knight Therapeutics. “Chronic ITP continues to pose significant challenges for many patients, and we are proud to introduce a differentiated therapeutic treatment option for those who have not benefited from existing therapies. This milestone reflects our ongoing commitment to strengthening our presence in the region and providing meaningful solutions to the patients and physicians who need them.”

Knight announced its agreement with Rigel Pharmaceuticals, Inc. in May 2022, securing exclusive rights to commercialize TAVALISSE^® in Latin America. Since entering the agreement, Knight has made significant regulatory progress throughout the region and has submitted TAVALISSE^® for regulatory approval in Brazil, Colombia, Mexico, Argentina and Paraguay. Knight obtained regulatory approval in Mexico in 2024. In May 2026, Knight announced the regulatory approval for TAVALISSE^® in Brazil and expects to launch the product commercially in the second half of 2026.

About TAVALISSE^® (fostamatinib disodium hexahydrate)

Fostamatinib is an orally administered spleen tyrosine kinase (SYK) inhibitor. It is currently marketed in the United States under the brand name TAVALISSE (100mg and 150mg tablets) and in Europe under the brand name TAVLESSE for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment.²

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.³ 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.⁴ Current therapies for ITP in Mexico include steroids, blood platelet production boosters like thrombopoietin receptor agonists (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies.⁵ 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=150), and the open‑label FIT‑3 extension. Patients received fostamatinib 100 mg twice daily for 24 weeks with an optional increase to 150 mg twice daily after one month.²

Across FIT‑1 and FIT‑2, the primary endpoint—stable platelet response (≥50 × 10⁹/L at ≥4 of 6 assessments during Weeks 14–24, without rescue therapy)— was achieved by 18% of patients on fostamatinib vs. 2% on placebo (P = .0003). Overall responses (defined retrospectively as ≥1 platelet count ≥50 000/μL within the first 12 weeks on treatment) occurred in 43% of patients on fostamatinib vs. 14% on placebo (P = .0006)⁶. In FIT‑3, 23% of patients newly treated with fostamatinib (treated with placebo in the prior studies) achieved a stable response.¹ 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 x 10⁹/L for 12 months or longer.¹

The most common adverse reactions (≥5%) included diarrhea, hypertension, nausea, dizziness, elevated ALT/AST, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.⁶ Serious adverse drug reactions reported in 1% of patients included febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis.⁶

About Knight Therapeutics Inc.

Knight Therapeutics Inc., 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 Inc. 's shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company 's web site at www.knighttx.com or www.sedarplus.ca.

Forward-Looking Statements for Knight

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc. 's Annual Report and in Knight Therapeutics Inc. 's Annual Information Form for the year ended December 31, 2025, as filed on www.sedarplus.ca. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

1. COFEPRIS. Approved Information.
   https://tramiteselectronicos02.cofepris.gob.mx/BuscadorPublicoRegistrosSanitarios/BusquedaRegistroSanitario.aspx. Accessed April 1^st, 2026. Restricted to Mexican IP domain.
2. Tavalisse. Full Prescribing Information. USPI 12/2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209299Orig1s003lbl.pdf. Accessed March 24^th 2026
3. National Heart, Lung, and Blood Institute. Immune Thrombocytopenia. U.S. Department of Health and Human Services.
   https://www.nhlbi.nih.gov/health/immune-thrombocytopenia. Accessed 24 July 2025.
4. Kos, Marek et al. “The Many Faces of Immune Thrombocytopenia: Mechanisms, Therapies, and Clinical Challenges in Oncological Patients.” Journal of clinical medicine vol. 13,22 6738. 8 Nov. 2024, doi:10.3390/jcm13226738
5. Kuter, D. "The treatment of immune thrombocytopenia (ITP) – focus on thrombopoietin receptor agonists " Annals of Blood, vol. 6, 2021. https://aob.amegroups.org/article/view/6335/html. Accessed 24 July 2025.
6. Bussel, James et al. “Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials.” American journal of hematology vol. 93,7 (2018): 921-930. doi:10.1002/ajh.25125
   
   

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