Proposed seamless design would incorporate previously FDA-cleared dose-optimization work into a single registration-intent program aligning it with Company’s capital-efficient development strategy
PHILADELPHIA, Sept. 29, 2026 (GLOBE NEWSWIRE) — Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today announced that it has submitted an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration (“FDA”) for Teverelix®, its investigational, next generation, long-acting GnRH antagonist, in advanced prostate cancer (“APC”) patients at increased cardiovascular (“CV”) risk.
The submission is designed to establish a defined, capital-efficient and partner-ready registrational pathway for Teverelix without Medicus independently funding an additional clinical development study in the APC program at this time. Importantly, the proposed design is stage-gated: it begins with approximately 80 randomized patients, incorporating and replacing the previously FDA-cleared stand-alone 40-patient open-label Phase 2b dose-optimization study. Once predefined continuation criteria have been satisfied, the program would then proceed to add approximately 528 patients, for approximately 608 patients in total, with eligible patients from the initial stage contributing to the final registration analyses.
If the FDA agrees with the proposed approach, Medicus believes the optimized design could reduce the overall planned clinical development program from approximately 1,500 patients to approximately 600 patients while providing a single pathway encompassing dose optimization, androgen suppression and prospective evaluation of cardiovascular differentiation in APC patients at increased cardiovascular risk, without an upfront commitment to enroll the full study population.
Following FDA feedback, and subject to the nature of that feedback, Medicus’ intent is to seek to out-license or otherwise strategically partner the Teverelix APC program rather than independently fund execution of the proposed registrational study.
There can be no assurance that the FDA will agree with the proposed protocol, that the optimized development pathway will ultimately support registration, or that Medicus will successfully enter into a licensing or other strategic transaction involving Teverelix.
Management Commentary
“Our objective with this submission is not to commit Medicus capital to another APC clinical study—it is to define the most efficient registrational pathway possible and make Teverelix ready for a strategic partner,” stated Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. “The FDA previously cleared a 40-patient open-label dose-optimization study. Rather than independently funding that study, we have now proposed an approximately 600-patient seamless registration-intent program that incorporates a more rigorous 80-patient randomized dose-optimization stage and could reduce the overall development population from ~ 1,500 patients to ~ 600 and is more likely to be partner-ready.”
Designed to Reach Partner Readiness Without Additional Medicus R&D Spend
The submission represents a further implementation of the Company’s capital-efficient portfolio strategy announced on September 8, 2026, under which Medicus is concentrating capital and organizational resources on programs where focused clinical development may offer the most compelling risk-adjusted opportunity.
Medicus’ objective with the current FDA submission is to complete the regulatory optimization of the Teverelix APC development pathway before committing additional internal capital to clinical execution.
If the FDA provides constructive feedback on the proposed approach, Medicus intends to use the resulting regulatory-defined development pathway as the basis for strategic partnering discussions and seek a pharmaceutical partner to fund and execute subsequent APC clinical development and commercialization
From FDA-Cleared Dose Optimization to a Seamless Registration-Intent Program
On February 10, 2026, Medicus announced that FDA had provided “Study May Proceed” clearance for a 40-patient open-label Phase 2b dose-optimization study of Teverelix in men with advanced prostate cancer appropriate for androgen deprivation therapy. That study was designed to confirm the Teverelix dosing regimen and sustained testosterone suppression.
In addition to focusing its efforts towards GMP grade manufacturing, quality-release, and other clinical study readiness steps, which are anticipated to be completed before the end of this year, the Company continued to optimize the APC development strategy. The newly submitted protocol proposes an approximately 80-patient randomized dose-optimization stage as the first part of an approximately 608-patient seamless Phase 2b/3 registration-intent study. Subject to predefined criteria, the study would then continue with approximately 528 additional patients, with eligible patients from the initial stage contributing to the final registration analyses.
The proposed design is intended to avoid conducting a stand-alone dose-optimization study followed by a separate, substantially larger Phase 3 program. Compared with a previously discussed development approach involving approximately 1,500 patients, the seamless strategy could reduce total planned enrollment by approximately 60% while reducing duplication, time and capital requirements associated with sequential studies.
Cardiovascular-Focused Registrational Strategy
The optimized strategy incorporates emerging randomized clinical evidence published in JAMA Cardiology in 2026 showing that differences in coronary plaque progression between GnRH treatment pathways can be objectively measured over 12 months using non-invasive coronary CT angiography (“CCTA”). CCTA can be incorporated into a multicenter study using standardized scans at baseline and Month 12 with blinded central quantitative analysis.
The proposed protocol combines established testosterone-suppression requirements with a 12-month coronary non-calcified plaque endpoint, while allowing longer-term cardiovascular event follow-up to continue in the same patients. The development strategy is designed to evaluate whether Teverelix can achieve effective androgen deprivation while demonstrating cardiovascular differentiation in advanced prostate cancer patients already at increased CV risk.
If the FDA agrees that this approach could support registration, Medicus believes the proposed design could provide a substantially shorter and more capital-efficient development pathway than the previously contemplated sequential program. Any development timeline remains subject to FDA feedback, successful study execution, enrollment, clinical results and regulatory review.
About Teverelix®
Teverelix® is an investigational next-generation, long-acting GnRH antagonist formulated as a microcrystalline suspension. Unlike GnRH agonists, which induce an initial testosterone surge, Teverelix provides immediate receptor antagonism, enabling rapid suppression of luteinizing hormone, follicle-stimulating hormone and downstream sex hormones without flare. Medicus is evaluating Teverelix across hormone-dependent indications and is pursuing a capital-efficient development strategy intended to advance programs through regulatory and clinical value-creating milestones while evaluating strategic partnership opportunities.
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 advancing the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.
The Company’s current therapeutic assets are:
CD228V ADC, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, directed against melanotransferrin (CD228), a cell-surface protein expressed across multiple solid tumor types, such as melanoma, squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal cancer.
SkinJect®, an investigational novel localized immuno-oncology precision product focused on basal cell carcinoma (BCC) lesions in Gorlin Syndrome patients, a rare autosomal dominant disease also called nevoid BCC syndrome.
Teverelix®, an investigational next-generation GnRH antagonist, is being developed as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients, patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate and symptomatic endometriosis.
Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes “forward-looking statements” or “forward-looking information” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws (collectively, “forward-looking statements”). “Forward-looking statements” are 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 development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, 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, the FDA’s feedback regarding the Company’s Phase 2b/3 registration-intent protocol for Teverelix® in APC, the proposed design of the Phase 2b/3 registration-intent program, the potential to reduce the overall planned APC clinical development program from approximately 1,500 patients to approximately 600 patients, the establishment of a defined, capital-efficient and partner-ready registrational pathway for Teverelix® without Medicus independently funding an additional APC clinical development study, Medicus’ intent and ability to out-license or otherwise strategically partner the Teverelix® APC program, the anticipated completion of GMP-grade manufacturing, quality-release and other clinical study readiness steps before the end of 2026, whether the proposed cardiovascular-focused registrational strategy, including the 12-month non-calcified coronary plaque endpoint assessed using non-invasive coronary CCTA and the evaluation of Teverelix® effects on APC patients at increased cardiovascular risk, could support registration, the Company’s capital-efficient portfolio strategy and the anticipated benefits thereof, the Company’s co-development with Pfizer with respect to CD228V and the anticipated benefits thereof, the Company’s plans and expectations relating to the development, manufacture and commercialization of CD228V across human therapeutic indications, including the Company’s intention to focus initial development on melanoma with potential subsequent development in squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and esophageal cancer, the timing, design, conduct and results of any future clinical study of CD228V, and the potential market opportunities related to CD228V, SkinJect® and Teverelix® and the Company’s other therapeutic assets. 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.
