Knight Therapeutics Announces Relaunch of ORGOVYX® in Canada

MONTREAL, Oct. 07, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has relaunched ORGOVYX^® (relugolix) in Canada.

In June 2024, Knight and Sumitomo Pharma America Inc. (“SMPA”) announced that Knight and SMPA’s affiliates had entered into exclusive license and supply agreements to commercialize MYFEMBREE^® (relugolix/estradiol/norethindrone acetate), ORGOVYX^® (relugolix) and vibegron in Canada, as well as an asset purchase agreement under which Knight acquired certain mature products (the “Mature Products”, together with MYFEMBREE^®, ORGOVYX^® and vibegron, the “Products”).

ORGOVYX^® (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by Health Canada for the treatment of adult patients with advanced prostate cancer. ORGOVYX^® was approved in October 2023 and launched in March 2024. In February 2025, the pan-Canadian Pharmaceutical Alliance (“pCPA”) negotiations were concluded successfully and ORGOVYX^® has since received public listing in most provinces across Canada. ORGOVYX^® competes in the GnRH (Gonadotropin-releasing hormone) agonist and antagonist market for prostate cancer, which, based on IQVIA, is valued at over $200 million and has been growing at a five-year CAGR of 8%.

"ORGOVYX^® offers health care professionals a convenient oral alternative to rapidly suppress testosterone production for patients with prostate cancer. This new therapeutic option empowers clinicians to align treatment with each patient’s unique needs, helping optimize the best possible outcomes," said Samira Sakhia, President and CEO of Knight. “ORGOVYX^® is synergistic with our existing oncology portfolio with TRELSTAR^® and will allow Knight to leverage our existing infrastructure."

About ORGOVYX^® (relugolix)

ORGOVYX^® (relugolix 120mg tablets) is the first and only oral GnRH receptor antagonist approved by Health Canada for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX^® blocks the pituitary GnRH receptor, thereby reducing the release of the luteinizing and follicle-stimulating hormones, and consequently reducing the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.¹ According to IQVIA, sales of ORGOVYX^® in Canada were approximately $1.2 million in 2024.

About Prostate Cancer

Prostate cancer is the most prevalent malignancy in Canadian men; in 2023, an estimated 24,700 men were diagnosed while approximately 4,700 died of their disease. Lifetime risk of developing prostate cancer is approximately 1-in-8 and approximately 3% of all deaths of Canadian men are caused by the disease.² Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease.³

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty 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

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, 2024, 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. Sumitomo Pharma. (2023, October 30). ORGOVYX (relugolix tablets, 120 mg): Product monograph. Retrieved July 24, 2025, from https://pdf.hres.ca/dpd_pm/00073150.PDF
2. Fraser, M. (2023). The landscape of prostate cancer research in Canada. Journal of Clinical Oncology, 41(6_suppl), 394. https://doi.org/10.1200/JCO.2023.41.6_suppl.394
3. Urology Care Foundation. (n.d.). Advanced prostate cancer. UrologyHealth.org. Retrieved July 21, 2025, from https://www.urologyhealth.org/urology-a-z/p/prostate-cancer
   
   

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