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 ...

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 intervention. PHILADELPHIA, March 16, 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 that Babar K. Rao, MD, FAAD, an internationally recognized academ ...

Core Insights - Medicus Pharma has reported promising data from its Phase 2 clinical trial for SkinJect, a non-invasive treatment for basal cell carcinoma, indicating a potential reduction in the need for surgical interventions [1][3][5] Company Updates - The CEO of Medicus Pharma, Raza Bokhari, expressed excitement over the Phase 2 dataset, which shows that approximately 75% of treated patients may not require Mohs surgery, addressing a significant unmet medical need [3][5] - The clinical trial demonstrated a 73% clinical or visual clearance rate at day 57 for the 200 microgram cohort following excisional biopsy, which is considered very promising by clinicians [4][9] Industry Context - There are nearly 5 million new cases of basal cell carcinoma diagnosed annually in the U.S., with a backlog of over a million procedures due to a shortage of trained Mohs surgeons, highlighting the urgent need for effective treatments [4] - The microneedle technology used in SkinJect is patent protected and shows biological activity, especially when loaded with doxorubicin, enhancing clinical outcomes [6][8] Regulatory and Future Plans - Medicus Pharma is preparing for an end-of-Phase 2 meeting with the FDA to discuss the design of a pivotal study, with expectations to submit a request by mid-2023 [5][10] - The company aims to secure a strategic partner for co-development of the therapy, which could potentially lead to a blockbuster product [9][10]

Core Insights - Medicus Pharma Ltd. will participate in the Longwood Miami CEO Forum, focusing on its AI-enabled drug development strategy aimed at enhancing clinical trial efficiency [1][2] - The company is actively engaged in developing innovative therapeutics, including a non-invasive treatment for basal cell skin cancer and a next-generation GnRH antagonist for prostate cancer [1][2] Company Participation and Events - Dr. Raza Bokhari, Executive Chairman & CEO, will be part of a panel titled "Accelerating the Path to Patient Care" at the Longwood Miami CEO Forum on March 12-13, 2026 [1] - The event will feature notable industry leaders and aims to foster discussions on healthcare innovation [1] Strategic Collaborations and Developments - Medicus has entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore joint development opportunities in mRNA technology [1][2] - The company completed the acquisition of Antev, focusing on a new treatment for advanced prostate cancer, which may improve patient compliance and outcomes [1][2] Clinical Trials and Regulatory Approvals - The company has received regulatory approvals in the UK for its Phase 2 clinical study evaluating D-MNA for treating basal cell carcinoma [2] - Medicus has successfully enrolled 90 patients in the U.S. for the same study and anticipates an end-of-Phase 2 meeting with the FDA in the first half of 2026 [2] Future Plans and Innovations - Medicus plans to collaborate with Reliant AI Inc. to develop an AI-driven clinical data analytics platform to enhance clinical trial efficiency [2] - The company has received FDA clearance to initiate a Phase 2b dose-optimization study of Teverelix for advanced prostate cancer [2]

Core Insights - Medicus Pharma Ltd. has announced positive topline results from its Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin, with plans to finalize the Clinical Study Report (CSR) by Q2 2026 to support an end of Phase 2 meeting with the FDA [1][2][7] Clinical Study Overview - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular type BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] Topline Results - At Day 29 post-treatment, the clinical clearance rates were 33% for placebo, 47% for the 100µg D-MNA group, and 40% for the 200µg D-MNA group; histological clearance rates were 20%, 24%, and 27% respectively [4] - At Day 57, the 200µg cohort showed the highest activity with 73% clinical clearance and 40% histological clearance [4][6] Management Commentary - The CEO of Medicus expressed encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and strengthens the company's position in potential partnerships [6][7] Regulatory and Strategic Focus - The final CSR, including full safety analyses, is expected to be completed by Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The company aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [9]

Core Insights - Medicus Pharma Ltd. announced positive topline results from its Phase 2 clinical study (SKNJCT-003) for Doxorubicin Microneedle Array (D-MNA) aimed at treating basal cell carcinoma (BCC) of the skin, indicating potential for FDA engagement and partnership readiness [1][2] Clinical Study Design and Results - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] - Topline results showed that at Day 29, the clinical clearance rates were 33% for placebo, 47% for 100µg D-MNA, and 40% for 200µg D-MNA; at Day 57, the rates improved to 38% for placebo, 42% for 100µg D-MNA, and 73% for 200µg D-MNA, with histological clearance rates of 20%, 24%, and 27% respectively at Day 29, and 38%, 33%, and 40% at Day 57 [4] Management Commentary - The CEO of Medicus expressed strong encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and enhances the company's position in potential partnership discussions [6] Regulatory and Strategic Focus - The final Clinical Study Report (CSR) is expected to be completed in Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The study was not powered for registrational endpoints, and no conclusions regarding regulatory approval can be drawn at this time [8] - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue strategic partnerships for late-stage development and commercialization [9]

Core Insights - Medicus Pharma Ltd. is set to celebrate its one-year anniversary as a Nasdaq-listed company by ringing the Nasdaq Opening Bell on January 22, 2026, highlighting its focus on disciplined execution and clinical development [1][4] Company Overview - Medicus Pharma Ltd. is a precision-guided biotech/life sciences company dedicated to advancing clinical development programs for novel therapeutics [5] - The company operates across multiple countries on three continents [5] Clinical Pipeline - The current pipeline includes SkinJect, a localized immunogenic precision therapy for basal cell carcinoma, targeting a market opportunity estimated at $2 billion, and Teverelix, a next-generation GnRH antagonist for advanced prostate cancer patients, representing a combined market opportunity of approximately $6 billion [3][6] Recent Developments - The SkinJect program is nearing database lock and clinical data readout, which may lead to potential partnering opportunities [4][16] - Medicus has completed enrollment of 90 patients in the Phase 2 clinical study (SKNJCT-003) for SkinJect, with topline results expected in Q1 2026 [16] - The company has received regulatory approvals in the UK to expand the ongoing Phase 2 study for SkinJect [15] Collaborations and Partnerships - In August 2025, Medicus entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore mutual interests in mRNA platform development [7][8] - The company acquired Antev, a UK-based biotech firm, to develop Teverelix, which is designed to directly suppress sex hormone production without an initial testosterone surge, potentially reducing cardiovascular risks [9][10] Regulatory Milestones - The FDA has provided guidance on the proposed Phase 3 trial design for Teverelix, supporting its development for advanced prostate cancer patients with increased cardiovascular risk [12] - The FDA approved the Phase 2b study design for Teverelix in advanced prostate cancer and acute urinary retention relapse, covering 40 and 390 patients respectively [13][14] Future Plans - Medicus plans to collaborate with Reliant AI Inc. to develop an AI-driven clinical data analytics platform to enhance clinical development efficiency [17][18]

Core Viewpoint - Medicus Pharma has completed patient enrollment in its SkinJect clinical trial, marking a significant milestone in the development of a noninvasive treatment for basal cell carcinoma, the most common skin cancer [1][4]. Company Overview - Medicus Pharma is advancing its clinical development program for SkinJect, a novel treatment targeting non-melanoma skin diseases, particularly basal cell carcinoma [3][4]. - The company has been working on this project since the fall of 2023, with patient recruitment starting in August 2024 [4]. Clinical Trial Details - The clinical trial has enrolled 90 patients across nine sites in the United States [1][4]. - The company aims to present topline data in Q1 2026 and plans to sync with the FDA for an end-of-phase-two meeting in the first half of next year [4][8]. Treatment Methodology - SkinJect utilizes uniquely designed microneedle arrays developed from Carnegie Mellon and the University of Pittsburgh, allowing for direct application of a chemotherapeutic agent, doxorubicin, to the cancer site [6]. - This method is intended to trigger an immunogenic response and effectively kill cancer cells [6]. Market Context - Non-melanoma skin diseases, especially basal cell carcinoma, account for 5 million new cases annually in the United States and over 30 million globally [5]. - Traditional treatments like Mohs surgery are expensive and painful, highlighting the need for a more cost-effective and aesthetically pleasing alternative [5][7]. Future Outlook - The company is optimistic about the upcoming topline data and the potential for a Priority Review Voucher from the FDA, which could expedite the new drug application timeline by 10-12 months [8][9]. - The NDA is expected to be filed in late 2027 or early 2028, aligning with the company's positive momentum [8][9].

As filed with the Securities and Exchange Commission on November 19, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ (State or other jurisdiction of incorporation or organization) Ontario, Canada 2834 98-1778211 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ide ...

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]