PHILADELPHIA, PA — November 13, 2025 — Leads & Copy — Medicus Pharma Ltd. (NASDAQ:MDCX) has received regulatory and ethical approvals in the United Kingdom to expand its Phase 2 clinical study (SKNJCT-003) of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin.
The approvals, granted by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), and the Wales Research Ethics Committee (WREC), allow the study to expand beyond its current nine clinical sites in the United States.
Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO, stated that the U.K. approval marks a significant step in establishing a global presence for the non-invasive BCC treatment, estimating a potential market opportunity exceeding $2 billion. With active clinical programs in the United States, Europe, and the Middle East, the company aims to enhance global patient recruitment and clinical data.
The MHRA approval followed a review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA confirmed compliance with U.K. Good Clinical Practice and National Health Service (NHS) standards.
The SKNJCT-003 study is a randomized, double-blind, placebo-controlled, multi-center trial enrolling up to 90 subjects with BCC. Participants are randomized 1:1:1 into three groups: a placebo group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The high-dose D-MNA was previously tested in a Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021. SKNJCT-001 met its primary objective of safety and tolerability, with D-MNA being well-tolerated across all dose levels and demonstrating complete responses in six participants.
Medicus Pharma also has an ongoing clinical study (SKNJCT-004) in the United Arab Emirates (UAE), involving 36 patients across six sites. Additionally, the company completed the acquisition of Antev, a UK-based biotech company, in August 2025, which is developing Teverelix for cardiovascular high-risk advanced prostate cancer patients.
In October 2025, Medicus announced a collaboration with the Gorlin Syndrome Alliance (GSA) to provide compassionate access to SKINJECT™ for patients with Gorlin Syndrome, pursuing an Expanded Access IND Program with the FDA.
Carolyn Bonner, President and Acting Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.com
Medicus Pharma Ltd. is focused on advancing the clinical development programs of novel therapeutics assets and has active clinical studies in the United States, Europe, and the Middle East.
SkinJect Inc., a subsidiary, is focused on commercializing a non-invasive treatment for basal cell skin cancer using a dissolvable microneedle patch.
Source: Medicus Pharma Ltd
