European regulatory filing supports planned 2026 initiation of Phase 2b study of Teverelix® in an underserved population representing ~$4 billion annual market opportunity
PHILADELPHIA, June 08, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced the successful submission of a substantial modification application through the European Union Clinical Trials Information System (CTIS) supporting the planned Phase 2b study of Teverelix® in advanced prostate cancer (APC).
The submission represents an important milestone in Medicus’ strategy to advance Teverelix® toward registrational development focused on one of the largest unmet needs in prostate cancer treatment: patients with elevated cardiovascular risk requiring androgen deprivation therapy (ADT).
“Cardiovascular disease remains one of the most significant challenges facing men undergoing androgen deprivation therapy,” stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO, “We believe Teverelix’s® unique pharmacologic profile, including flare-free rapid testosterone suppression, profound follicle-stimulating hormone suppression and a long-acting depot formulation, may offer meaningful advantages for this patient population. This study is intended to generate the data necessary to support registrational planning and advance discussions with regulatory authorities in Europe and the United States.”
The planned Phase 2b study is designed to optimize dose selection and further characterize the pharmacokinetic, pharmacodynamic, efficacy and safety profile of Teverelix® ahead of planned registrational development. Medicus has previously engaged extensively with the U.S. Food and Drug Administration regarding its APC development strategy, including future studies focused on patients with elevated cardiovascular risk.
Teverelix®: Differentiated Mechanism with Cardiovascular Relevance
Teverelix® is a long-acting GnRH antagonist designed to provide rapid, flare-free testosterone suppression together with profound follicle-stimulating hormone (FSH) suppression through a convenient depot formulation. The Company believes these characteristics may provide meaningful differentiation from traditional GnRH agonists and support evaluation in patients where cardiovascular outcomes are of particular importance.
Advanced prostate cancer remains one of the largest oncology markets worldwide, with ADT serving as the backbone of treatment for hundreds of thousands of patients annually. Cardiovascular disease is increasingly recognized as a leading cause of mortality among men with advanced prostate cancer, with published studies suggesting that approximately 20% to 60% of APC patients have underlying cardiovascular disease and approximately 30% of patients requiring ADT have elevated cardiovascular risk. Despite this significant burden, no hormonal therapy currently carries a regulatory label specifically addressing treatment of high cardiovascular-risk prostate cancer patients.
While currently approved GnRH antagonists have demonstrated encouraging cardiovascular findings in clinical studies, no hormonal therapy has been specifically developed or prospectively positioned for patients with elevated cardiovascular risk. Medicus believes Teverelix® may provide an opportunity to address this important unmet need through a dedicated development strategy focused on this patient population.
The Company estimates that advanced prostate cancer patients with elevated cardiovascular risk represent an approximately $4 billion annual market opportunity across major pharmaceutical markets. Medicus believes that a differentiated therapy supported by prospective clinical data in this patient population could address a significant unmet medical need while creating substantial long-term commercial value.
Subject to regulatory review and authorization, Medicus intends to initiate patient enrollment later this year. Data generated from the Phase 2b study are expected to inform dose selection, registrational study design and future regulatory interactions in both Europe and the United States.
Medicus’ goal is to establish Teverelix® as the best-in-class hormonal therapy prospectively developed for advanced prostate cancer patients where cardiovascular risk is a major treatment consideration.
For further information contact:
Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.
The Company’s current key therapeutics assets are:
SkinJect®, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing a ~$2 billion annual market opportunity.
Teverelix®, a next-generation GnRH antagonist, is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing a ~$6 billion annual market opportunity.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the collaboration with Gorlin Syndrome Alliance (GSA) including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect®), ability to be approved for the Registrational IND Program to enable those suffering with Gorlin Syndrome to access SkinJect® under physician-supervised treatment protocols, the submission of Protocol SKNJCT-005 and the design, timing, conduct and results of the SKNJCT-005 Phase 2b registrational study, including whether the resulting data will be sufficient to support a future New Drug Application for SkinJect® in Gorlin Syndrome, the potential for SkinJect® to become the first FDA-approved lesion-directed therapy for patients with Gorlin Syndrome and a new standard of care for this patient population; and the Company's intention to apply for a Rare Pediatric Disease Priority Review Voucher and the potential issuance and benefits of such voucher, Orphan drug designation for SkinJect®, the development of Teverelix® and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the memorandum of understanding with HelixNano, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company’s submission for approval in the FDA Commissioner's National Priority Voucher program plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect® through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectations regarding reported efficacy findings, the overall response rate and potential changes thereto, and whether there will be material changes to its reported SKNJCT-003 topline results and to secure an EOP2 meeting with the FDA in the second half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", “could,” “designed,” "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2025, and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
