MONTREAL, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of JORNAY PM™ (methylphenidate HCI extended-release capsules) in Canada. JORNAY PM™ is an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children 6-12 years of age.¹

“Effective ADHD management begins with helping children transition smoothly into their day. JORNAY PM™ is delivered through an innovative delayed release/extended-release technology that provides smooth onset of effect at waking that not only provides therapeutic benefits when the child wakes up, but also provides therapeutic benefits that last into the early evening. This first and only evening-dosed methylphenidate treatment offers a new option for managing ADHD symptoms in children,” said Dr. Doron Almagor (MD, FRCPC) Child, Adolescent, and Adult Psychiatrist.

"We are thrilled to introduce JORNAY PM™ to the Canadian market, offering a new and innovative treatment option for ADHD patients and their families. This launch represents our commitment to addressing the diverse needs of the ADHD community and support better daily management of ADHD symptoms," said Samira Sakhia, President and CEO of Knight.

In May 2024, Knight entered into an agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. (now part of Collegium Pharmaceutical, Inc.; Nasdaq: COLL), for the exclusive rights to distribute JORNAY PM™ in Canada and Latin America. Knight received the approval of JORNAY PM™ by Health Canada in November 2024.

According to IQVIA, the Canadian ADHD market totals approximately $1.25 billion in 2024 with methylphenidates representing over $500 million and growing at more than 14% compound annual growth rate (CAGR) over the last four years.

About ADHD²

ADHD is a chronic, often lifelong neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children and adolescents and 3-5% in adults.⁴ The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients’ symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current first-line pharmacotherapies for ADHD include long-acting methylphenidate or amphetamine-based psychostimulants and non-stimulants. Individual products for both differ in their delivery systems and release profiles to provide distinct durations of effect. However, not all patients derive adequate symptom coverage with currently available therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.

About JORNAY PM™

JORNAY PM™ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM™ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.

JORNAY PM™ was studied in two multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trials^3,4. Both studies met their primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful improvement in ADHD symptom control upon awakening, through the afternoon, and into the evening. In clinical trials with JORNAY PM™, the most frequent adverse events were insomnia, affect lability, headache, decreased appetite, increased diastolic blood pressure, and upper respiratory tract infection.¹

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 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, 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. Health Canada. Product Monograph: Jornay PM (methylphenidate hydrochloride delayed-release and extended-release capsules). Knight Therapeutics Inc, [2025]. Drug Product Database, https://pdf.hres.ca/dpd_pm/00078457.PDF 
2. CADDRA - Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https://adhdlearn.caddra.ca/wp-content/uploads/2022/08/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf
3. Childress, A. C., Cutler, A. J., Marraffino, A., McDonnell, M. A., Turnbow, J. M., Brams, M., DeSousa, N. J., Incledon, B., Sallee, F. R., & Wigal, S. B. (2020). A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: An evaluation of safety and efficacy throughout the day and across settings. Journal of Child and Adolescent Psychopharmacology, 30(1), 2–14. https://www.liebertpub.com/doi/10.1089/cap.2019.0070
4. Pliszka, S. R., Wilens, T. E., Bostrom, S., Arnold, V. K., Marraffino, A., Cutler, A. J., López, F. A., DeSousa, N. J., Sallee, F. R., Incledon, B., & Newcorn, J. H. (2017). Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 27(6), 474–482. https://www.liebertpub.com/doi/10.1089/cap.2017.0084

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