About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

The Company enters 2026 with Multiple Phase 2 Catalysts, AI-enabled drug development strategy, and regulatory optionality as SKNJCT-003 study approaches database lock, topline clinical data readout and partnering readinessPHILADELPHIA, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to an ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

The Company’s abstract, Evaluation of Teverelix in Healthy Female Volunteers, has been accepted for presentation at American Association of Clinical Endocrinology (AACE) Annual meeting 2026PHILADELPHIA, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that detailed clinical dat ...

Core Insights - Medicus Pharma Ltd. is set to present at the Biotech Showcase 2026, highlighting its focus on advancing clinical development programs for innovative therapeutics [1][2] Company Strategy - The company's strategy involves advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization [5] - Medicus aims to assemble decision-grade clinical, regulatory, and operational data packages aligned with its out-licensing strategy as data matures across its programs [5] Clinical Development Updates - The SkinJect™ Phase 2 program, designed to non-invasively treat basal cell carcinoma (BCC), has achieved execution milestones, including the completion of enrollment of 90 patients in a randomized, double-blind, placebo-controlled study [6][7] - Topline decision-grade Phase 2 results are expected to be reported in the first quarter of 2026, with plans for an End-of-Phase 2 meeting with the FDA in the first half of 2026 [8][31] - Interim findings from the study indicated greater than 60% clinical clearance in an exploratory analysis [9] Regulatory and Geographic Expansion - Medicus has expanded the clinical and regulatory footprint of SkinJect™ to support development and partnering readiness, including approvals in the UK and the UAE for ongoing studies [10][30] - The FDA provided positive feedback regarding the potential use of the 505(b)(2) regulatory pathway for SkinJect™ [11] Collaboration and Partnerships - Medicus has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at supporting capital-efficient clinical development [15][32] - The company is exploring co-development opportunities with Helix Nanotechnologies for thermostable infectious disease vaccines [17][23] Pipeline Expansion - The acquisition of Antev Limited has added Teverelix, a next-generation GnRH antagonist targeting advanced prostate cancer patients, to Medicus's pipeline [18][24] - Teverelix has shown promising results in previous clinical trials, including a Phase 2a study demonstrating a 97.5% probability of achieving castration levels of testosterone suppression [26] Patient Access Initiatives - Medicus is collaborating with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program for SkinJect™, aiming to provide access to patients with multiple or inoperable BCCs [19][29]

Core Insights - Medicus Pharma Ltd. has submitted an FDA Commissioner's National Priority Voucher application for its Doxorubicin Microneedle Array (D-MNA) to treat basal cell carcinoma (BCC), aligning with national health priorities [1][4][5] - The FDA's new approval pathway aims to expedite drug review times for products addressing significant public health needs, potentially reducing review times from 10-12 months to 1-2 months [2][3] Company Overview - Medicus Pharma Ltd. focuses on advancing clinical development programs for innovative therapeutics, with a particular emphasis on non-invasive treatments for skin cancer [1][24] - The company is actively engaged in clinical studies across multiple countries, including the United States and the United Arab Emirates [24] Clinical Development Program - The SKNJCT-003 program is a Phase 2 clinical study evaluating the efficacy of D-MNA in treating nodular BCC, with over 60% clinical clearance reported in interim analyses [11][12] - The study has expanded to include 90 participants, with over 75% already randomized [13] - A second clinical study, SKNJCT-004, has commenced in the UAE, with plans to randomize 36 patients [14][15] Public Health Impact - SkinJect addresses a significant public health issue by providing a non-surgical treatment option for BCC, which affects over five million new patients annually in the U.S. [6][17] - The treatment is particularly beneficial for patients with Gorlin syndrome, a rare genetic disorder leading to multiple BCCs, who often face repeated surgeries [10][21] Regulatory Developments - The FDA has indicated that products meeting specific criteria may receive accelerated approval, enhancing the potential for quicker market access for SkinJect [3][15] - Medicus has received regulatory approvals in the UK to expand its Phase 2 study, confirming compliance with local clinical standards [16][32] Strategic Collaborations - The company has entered a collaboration with the Gorlin Syndrome Alliance to facilitate expanded access to SkinJect for patients with recurrent or inoperable BCCs [21][22] - Medicus has also announced a memorandum of understanding with Helix Nanotechnologies to explore co-development of mRNA vaccines [18][25] Pipeline Expansion - Medicus completed the acquisition of Antev, a UK-based biotech company, to enhance its pipeline with Teverelix, a GnRH antagonist for advanced prostate cancer [19][20][26]

Core Insights - Medicus Pharma Ltd. has submitted an FDA Commissioner's National Priority Voucher (CNPV) application for its product Skinject (SKNJCT-003), which utilizes a Doxorubicin Microneedle Array (D-MNA) to treat basal cell carcinoma (BCC) non-invasively [1][4][5] - The CNPV program aims to expedite the review process for drugs that align with U.S. national health priorities, potentially reducing review times from 10-12 months to 1-2 months [2][3] - Skinject addresses a significant public health need, offering a non-surgical alternative for BCC treatment, which affects over five million new cases annually in the U.S. [6][7] Company Developments - The company is conducting a Phase 2 clinical study (SKNJCT-003) across nine clinical sites in the U.S., with a focus on evaluating lesion clearance rates and patient tolerability [10][11] - An interim analysis of SKNJCT-003 showed over 60% clinical clearance, with the study expanding to include 90 participants [11][12] - Medicus has received regulatory approvals in the U.K. to expand its Phase 2 study, confirming compliance with local clinical standards [15][32] Product and Technology - Skinject is a single-use, dissolvable microneedle array that delivers a localized therapeutic agent directly into BCC lesions, providing a cost-effective and minimally invasive treatment option [8][9] - The product specifically targets patients with Gorlin syndrome, a rare genetic disorder that leads to multiple BCCs, addressing their unmet medical needs [9][21] Strategic Collaborations - Medicus has entered a collaboration with the Gorlin Syndrome Alliance to facilitate expanded access to Skinject for patients with recurrent or inoperable BCCs [21][22] - The company also announced a non-binding memorandum of understanding with Helix Nanotechnologies to explore co-development of mRNA-based vaccines [18][25] Market Context - The CNPV program is part of a broader initiative by the FDA to enhance drug development for pressing health issues in the U.S., including cancer care access and affordability [2][3][4] - The introduction of Skinject is positioned to reduce healthcare costs and surgical dependence for BCC treatment, aligning with national health priorities [5][17]

Core Insights - Medicus Pharma Ltd. is advancing clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next-generation GnRH antagonist [1] Financial and Operational Results - The company announced its financial and operating results for the quarter ending September 30, 2025 [1] - Important corporate updates were highlighted in the announcement [1]

Core Insights - Medicus Pharma Ltd. has announced a strategic collaboration with the Gorlin Syndrome Alliance to enhance access to its investigational therapy SKINJECT™ for patients with Gorlin Syndrome, a rare genetic disorder that can lead to numerous basal cell carcinomas [1][2][5] Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on advancing clinical development programs for novel therapeutics [1][9] - The company is currently conducting a Phase 2 clinical study (SKNJCT-003) for SKINJECT™ across nine clinical sites in the United States, which began randomizing patients in August 2024 [5][10] - Medicus has also expanded its clinical studies to Europe and is conducting another study (SKNJCT-004) in the UAE, targeting a total of 36 patients [6][10] Product Development - SKINJECT™ is an investigational localized immunogenic therapy aimed at treating non-melanoma skin diseases, particularly basal cell carcinoma [3][10] - The Phase 2 study (SKNJCT-003) has shown promising interim results, with over 60% clinical clearance reported after randomizing more than 50% of the targeted 60 patients [5][10] - The FDA has provided positive feedback regarding the development of SKINJECT™, indicating a potential 505(b)(2) regulatory pathway for its approval [5][10] Collaboration and Community Engagement - The collaboration with the Gorlin Syndrome Alliance aims to facilitate expanded access to SKINJECT™ while integrating patient community insights into the treatment's development [2][5] - The Gorlin Syndrome Alliance serves as a bridge between patients, clinicians, researchers, and industry, promoting awareness and providing support for those affected by Gorlin Syndrome [18][19] Recent Acquisitions - In August 2025, Medicus completed the acquisition of Antev, a UK-based biotech company developing Teverelix, a next-generation GnRH antagonist for advanced prostate cancer patients [7][12] - Teverelix is designed to suppress sex hormone production without an initial surge, potentially reducing cardiovascular risks for patients with existing conditions [8][13]

Core Insights - The company is advancing its novel Doxorubicin containing Microneedle Array (D-MNA) treatment for non-invasive basal cell carcinoma (BCC) and developing Teverelix, a next-generation GnRH Antagonist for Acute Urinary Retention (AURr) and high cardiovascular risk prostate cancer [1] Market Opportunity - D-MNA and Teverelix collectively represent approximately $8 billion in potential market opportunity [1] Company Activities - The company will participate in a live fireside chat on September 29, 2025, hosted by Kumaraguru (Kumar) Raja, Ph.D. [1]