Knight Therapeutics Announces Regulatory Approval of TAVALISSE® in Colombia

MONTREAL, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. ( "Knight ") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has received regulatory approval from INVIMA, the Colombian health regulatory agency, for TAVALISSE^® (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response, loss of response, or intolerance to prior treatment with corticosteroids and intravenous immunoglobulin.¹

“We are pleased to receive regulatory approval of TAVALISSE in Colombia, providing an important new therapeutic option for adult patients living with chronic immune thrombocytopenia,” said Samira Sakhia, President and CEO of Knight Therapeutics. “This approval represents a meaningful step in addressing unmet medical needs in Colombia and underscores our ongoing commitment to expanding access to innovative treatments and improving patient outcomes across Latin America. We look forward to bringing TAVALISSE to patients and healthcare providers in Colombia in the near future.”

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 launched TAVALISSE in Mexico in May 2026 and expects to launch in Brazil in the fourth quarter of 2026 and in Colombia in the first half of 2027.

About TAVALISSE^®

TAVALISSE^® (fostamatinib disodium hexahydrate) 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

TAVALISSE^® is a registered trademark of Rigel Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

About Chronic Immune Thrombocytopenia (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

About Knight Therapeutics Inc.

Knight Therapeutics Inc., 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. Knight Therapeutics Inc. 's shares trade on the 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. INVIMA, Prescribing Information. Approved on August 31, 2026
2. Tavalisse. Full Prescribing Information. USPI 12/2024
   https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209299Orig1s003lbl.pdf.
   Accessed June 2^nd 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
   
   

© 2026 GlobeNewswire, Inc. All Rights Reserved.

Read More..

The news, reports, views and opinions of authors (or source) expressed are their own and do not necessarily represent the views of CRWE World.