Medicus Pharma To Discuss Positive Skinject(R) Phase 2 Topline Results In Fireside Chat Hosted By Brookline Capital Markets Biotechnology Equity Research Analyst ELEMENT-- Back to the Newsroom Medicus Pharma To Discuss Positive Skinject(R) Phase 2 Topline Results In Fireside Chat Hosted By Brookline Capital Markets Biotechnology Equity Research Analyst Phase 2 Study Demonstrated 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical ...

The Company Reported 73% Clinical Clearance in the 200-µg cohort at Day 57PHILADELPHIA, March 09, 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 provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for ...

Core Insights - The company is developing Teverelix® as a leading product for advanced prostate cancer patients with high cardiovascular risk and as a first-in-class treatment for Acute Urinary Retention Relapse prevention, representing a combined market opportunity of approximately US$6 billion [1][20]. Clinical Development - The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer, with a total treatment duration of approximately 22 weeks [2]. - The primary endpoint is to confirm medical castration by Day 29 with sustained suppression through Day 155, targeting a probability exceeding 90% [2][9]. Mechanism of Action - Teverelix is a long-acting injectable GnRH antagonist that provides immediate receptor antagonism, allowing for rapid suppression of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and downstream sex hormones without an initial testosterone surge [4][21]. - This mechanism is particularly relevant for patients with advanced prostate cancer and elevated cardiovascular risk, as GnRH agonists may contribute to adverse cardiovascular outcomes [5][6]. Target Patient Population - Teverelix is specifically developed for advanced prostate cancer patients with objectively defined cardiovascular risk, including those with recent major adverse cardiovascular events (MACE) or severe subclinical atherosclerosis [7]. - Approximately 300,000 to 500,000 men in the U.S. are living with advanced prostate cancer, representing an estimated annual market opportunity exceeding US$4 billion [7]. Regulatory Strategy - The company has received FDA clearance to initiate the Phase 2b study and has aligned on a development indication focused on hormone therapy for advanced prostate cancer patients with increased cardiovascular risk [10][23]. - A clear Phase 3 framework is defined to evaluate sustained castration efficacy alongside cardiovascular outcomes, which may establish Teverelix as a new therapeutic backbone for patients where cardiovascular safety is critical [11][10]. Strategic Partnerships - The company is well-positioned for strategic partnership discussions, particularly with organizations seeking differentiated late-stage oncology assets supported by a clear regulatory and labeling strategy [12]. - The development strategy includes advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships for late-stage development and commercialization [13]. Additional Programs - Medicus is also advancing SkinJect™, a proprietary dissolvable microneedle array platform for the non-invasive treatment of basal cell carcinoma, with topline decision-grade data expected in Q1 2026 [14][27].

Core Insights - The amendment to the license agreement reduces the royalty rate on Teverelix® from approximately 4% to 2%, while maintaining global rights and intellectual property control [1][2] - Teverelix® is being developed as a first-in-class product for Acute Urinary Retention relapse prevention and as a best-in-class treatment for prostate cancer patients with high cardiovascular risk, representing a potential market opportunity of around US$6 billion [1][3] License Agreement Details - The amended agreement clarifies the royalty term on a country-by-country basis and does not change the scope of the license or the underlying intellectual property [2] - Medicus retains exclusive worldwide rights to develop, manufacture, and commercialize Teverelix, including the ability to grant sublicenses, which supports flexible global partnering strategies [3][4] Economic Impact - The reduced royalty burden is expected to enhance Teverelix's attractiveness for future partnerships, particularly for late-stage development and commercialization [3] - The amendment reflects scientific progress and intellectual property expansion achieved by the Antev team, aligning the parties under a simplified economic framework [5] Development Strategy - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [10] - The company is focused on assembling decision-grade clinical and regulatory data packages to support its partnering-focused model [10] Clinical Development of Teverelix - Teverelix is a long-acting injectable GnRH antagonist that suppresses sex hormone production without an initial surge, potentially reducing cardiovascular risks for patients with existing conditions [7][18] - Previous studies have shown Teverelix to be well tolerated, with significant testosterone suppression achieved in clinical trials [19][20] SkinJect™ Program - Medicus is advancing its SkinJect™ program, a proprietary dissolvable microneedle array platform for treating basal cell carcinoma, with Phase 2 data expected in early 2026 [11][24] - The company has received regulatory approvals in the UK to expand its ongoing Phase 2 clinical study for SkinJect™ [23]