Knight Therapeutics Announces Relaunch of MYFEMBREE® 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 MYFEMBREE^® (relugolix/estradiol/norethindrone acetate) 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”).

MYFEMBREE^® is a fixed-dose combination of relugolix, estradiol, and norethindrone acetate and is the first oral prescription treatment for both the management of heavy menstrual bleeding associated with uterine fibroids and the management of moderate to severe pain associated with endometriosis in pre-menopausal women. MYFEMBREE^® was approved by Health Canada in September of 2023 and was launched in February 2024. Based on IQVIA, the total gonadotropin-releasing hormone receptor (GnRH) agonist and antagonist sales for endometriosis and uterine fibroids in Canada is estimated at $45 million and has been growing at a five-year CAGR of 8%. According to IQVIA Canada, in 2024, the sales of MYFEMBREE^® were approximately $2.9 million.

“The relaunch of MYFEMBREE^® provides physicians an effective treatment option for the management of uterine fibroids and endometriosis, conditions that continue to impact so many women,” said Samira Sakhia, President and CEO of Knight. “MYFEMBREE^® strengthens our women’s health portfolio and benefit from the synergies of our existing commercial and medical infrastructure.”

About MYFEMBREE^®

MYFEMBREE^® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg tablets) was approved by Health Canada in September 2023 making it the first oral prescription treatment for both the management of heavy menstrual bleeding associated with uterine fibroids and for the management of moderate to severe pain associated with endometriosis in pre-menopausal women.¹

About Uterine Fibroids

Uterine fibroids are the most common benign tumors found in women of reproductive age, occurring in 20–30% of females and 70–80% being detected by age 50.^2,3 They are frequently asymptomatic, although they can cause symptoms such as heavy menstrual bleeding, pelvic pressure or pain, urinary and bowel dysfunction, infertility, and pregnancy complications.⁴ Despite their high prevalence and impact, uterine fibroids remain underdiagnosed and undertreated, particularly in low-resource settings where access to screening and treatment is limited.⁵ A growing body of global epidemiological data highlights this gap, underscoring the urgent need for broader awareness, earlier diagnosis, and more non-invasive treatment options. Addressing this unmet need could drastically improve outcomes for millions of women worldwide.^6,7

About Endometriosis

Endometriosis is a chronic, inflammatory gynecological disorder affecting approximately 10% of reproductive-aged women globally and 7.0% of women aged 18–48 in Canada, yet it remains one of the most underdiagnosed and misunderstood conditions in women's health.⁸ Characterized by the presence of endometrial-like tissue outside the uterus, it leads to debilitating symptoms such as pelvic pain, infertility, fatigue, and significant impacts on daily functioning and mental health.⁹ Despite its high prevalence and burden, diagnostic delays often exceed 7–10 years, and current treatments are limited, often invasive, or fail to provide long-term relief.¹⁰

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.

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