Knight Therapeutics Announces Regulatory Submission of GEMTESA® in Canada

MONTREAL, Sept. 15, 2026 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (“Knight”) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) for GEMTESA^® (vibegron), proposed for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and OAB with symptoms of urge urinary incontinence, urgency, urinary frequency, and nocturia in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH), has been accepted for review by Health Canada.

“For patients living with overactive bladder, and for adult males managing OAB alongside BPH, having access to an effective treatment option can make a real difference in daily life,” said Samira Sakhia, President and Chief Executive Officer, Knight Therapeutics Inc. “The acceptance of our submission for GEMTESA^® in Canada is an important step toward bringing this therapy to the patients who need it. At Knight, our commitment goes beyond building our portfolio. We are dedicated to improving access to innovative therapies that improve patient outcomes. We are also pleased to advance this milestone together with our partner, Sumitomo Pharma America Inc.”

In June 2025, Knight entered into exclusive supply and distribution agreements with Sumitomo’s Pharma America (SMPA) to commercialize GEMTESA^®, as well as ORGOVYX^® (relugolix) and MYFEMBREE^® (relugolix/estradiol/norethindrone acetate) in Canada.

About GEMTESA^®

GEMTESA^® (vibegron) is marketed in the US for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults and in adult males taking medication for benign prostatic hyperplasia (BPH). GEMTESA^® works by selectively targeting β₃ adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity.¹

GEMTESA^® is a registered trademark of Sumitomo Pharma Co., Ltd. All other trademarks are the property of their respective owners.

About Overactive Bladder

Overactive Bladder (OAB) is a symptom syndrome characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.^2,3 These symptoms are commonly associated with involuntary contractions of the detrusor muscle, although they can also result from other forms of lower urinary tract dysfunction.² The pooled global prevalence of OAB was estimated at approximately 20%, with prevalence higher in women (nearly 22%) than in men (roughly 16%).⁴ Canadian population based estimates reported in the Canadian Urological Association (CUA) guideline from May 2017 indicate an overall prevalence of approximately 14 to 18%, with prevalence increasing with age.⁵

About Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH) is a histologic diagnosis describing the proliferation of smooth muscle and epithelial cells within the prostatic transition zone, which commonly leads to enlargement of the prostate gland.⁶ In men presenting with lower urinary tract symptoms (LUTS), the symptoms are frequently presumed to arise from bladder outlet obstruction caused by the enlarged prostate.⁶ Even when the bladder outflow obstruction is relieved surgically, storage symptoms consistent with overactive bladder (OAB) may persist; detrusor overactivity has been reported in approximately 20% to 40% of men.⁷ LUTS are conventionally divided into storage, voiding, and postmicturition symptoms.² In the population-based EPIC study, storage symptoms were the most prevalent category among men (51.3%), exceeding both voiding (25.7%) and postmicturition (16.9%) symptoms.⁸

BPH becomes increasingly prevalent with age, and symptoms of OAB, which are often associated with BPH, are frequently misattributed to normal aging. In the United States, approximately 14 million men are living with BPH, and up to 75% of these individuals experience OAB symptoms.^9,10 Despite this high prevalence, OAB symptoms in men often remain unrecognized, particularly in those with underlying BPH. It is estimated that up to 80% of OAB cases in men may go undiagnosed.^11,12

About The COURAGE Trial

The COURAGE trial (NCT03902080; URO-901-3005) was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating GEMTESA^® 75 mg once daily versus placebo over 24 weeks in men ≥45 years of age with symptoms of overactive bladder (OAB) who were receiving pharmacological therapy with α-blockers, with or without 5α-reductase inhibitors, for BPH. Of 1,105 participants randomized 1:1 to vibegron or placebo, 965 (87.3%) completed the trial. The study met both co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline versus placebo in mean daily micturitions (least squares mean difference −0.74; 95% CI −1.02, −0.46; P < .0001) and urgency episodes (−0.95; 95% CI −1.37, −0.54; P < .0001). GEMTESA^® also met all prespecified secondary endpoints, with significant reductions versus placebo in nocturia episodes and urge urinary incontinence (UUI) episodes. Adverse events occurring in ≥ 2% of participants were hypertension, COVID-19, UTI, and hematuria.¹³

About The EMPOWUR Trial

EMPOWUR was a 12-week, double-blind, placebo-controlled Phase 3 study evaluating vibegron 75 mg versus placebo in adults with OAB, as part of an extensive development program involving more than 4,000 OAB patients. The study demonstrated that treatment with GEMTESA^® resulted in statistically significant reductions in daily urge urinary incontinence episodes, micturition episodes, and urgency episodes, as well as an increase in volume voided, compared to placebo. A long-term extension of the EMPOWUR study was also conducted under double-blind conditions. The most common adverse reactions reported in 2% or more of patients treated with GEMTESA^® were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.^1,14

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 website 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. Sumitomo Pharma America, Inc. GEMTESA (vibegron) tablets, for oral use [prescribing information]. Revised February 2025. Accessed June 26, 2026. https://www.gemtesa.com/files/gemtesa-prescribing-information.pdf
2. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003;61(1):37-49. doi:10.1016/s0090-4295(02)02243-4
3. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012;188(6 Suppl):2455-2463. doi:10.1016/j.juro.2012.09.079
4. Zhang L, Cai N, Mo L, Tian X, Liu H, Yu B. Global Prevalence of Overactive Bladder: A Systematic Review and Meta-analysis. Int Urogynecol J. 2025;36(8):1547-1566. doi:10.1007/s00192-024-06029-2
5. Corcos J, Przydacz M, Campeau L, et al. CUA guideline on adult overactive bladder. Can Urol Assoc J. 2017;11(5):E142-E173. doi:10.5489/cuaj.4586
6. Lerner LB, McVary KT, Barry MJ, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline part I—initial work-up and medical management. J Urol. 2021;206(4):806-817. doi:10.1097/JU.0000000000002183
7. Andersson KE, Uvelius B. Changes in the rat urinary bladder after the relief of outflow obstruction – tracing targets for treatment of persistent symptoms in patients. Front Urol. 2022;2:1027086. doi:10.3389/fruro.2022.1027086
8. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50(6):1306-1315. doi:10.1016/j.eururo.2006.09.019
9. Deters LA. Benign prostatic hyperplasia (BPH). Medscape. Updated March 22, 2023. Accessed June 24, 2026. https://emedicine.medscape.com/article/437359-print
10. Dmochowski RR, Gomelsky A. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383
11. Burnett AL, Walker DR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348
12. Anger JT, Goldman HB, Luo X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourol Urodyn. 2018;37(1):213-222. doi:10.1002/nau.23276
13. Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999
14. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807

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