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 ...

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]

Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 As filed with the Securities and Exchange Commission on September 29, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 Id ...

As filed with the U.S. Securities and Exchange Commission on October 31, 2024. Registration No. 333-279771 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 9 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ Ontario, Canada 2834 98-1778211 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Cl ...

As filed with the U.S. Securities and Exchange Commission on October 29, 2024. Registration No. 333-279771 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 8 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ Ontario, Canada 2834 98-1778211 Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective dat ...

As filed with the U.S. Securities and Exchange Commission on October 15, 2024. Registration No. 333-279771 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 7 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ Ontario, Canada 2834 98-1778211 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Cl ...

As filed with the U.S. Securities and Exchange Commission on September 26, 2024. Registration No. 333-279771 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ Ontario, Canada 2834 98-1778211 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) ...

As filed with the U.S. Securities and Exchange Commission on September 23, 2024. Registration No. 333-279771 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ Ontario, Canada 2834 98-1778211 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) ...