Medicus Pharma Nears Key Data Readout for Novel Skin Cancer Therapy

PHILADELPHIA, PA – January 05, 2026 – As the biotech world converges on San Francisco for the annual Biotech Showcase, all eyes are on companies poised for a breakout year. Among them is Medicus Pharma Ltd. (NASDAQ: MDCX), a precision-guided life sciences company preparing for what could be its most transformative period to date. The company is set to present its strategy and upcoming catalysts on January 13, highlighted by the imminent release of pivotal Phase 2 clinical data for its lead asset, SkinJect™, a novel, non-invasive treatment for basal cell carcinoma (BCC).

With multiple clinical, regulatory, and pipeline expansion programs maturing, Medicus is executing a clear strategy: de-risk promising assets through mid-stage trials and forge strategic partnerships for late-stage development and commercialization. The upcoming data readout for SkinJect™ represents the first major test of this model in 2026, setting the stage for a year of significant inflection points.

Beyond the Scalpel: A New Approach to Skin Cancer

Basal cell carcinoma is the most diagnosed cancer in the United States, with over five million new cases annually. While surgical excision remains the standard of care, it can lead to scarring and complications, creating a substantial need for effective, non-invasive alternatives. The global market for BCC treatment, valued at nearly $3 billion in 2023, is projected to exceed $7 billion by 2030, driven by an aging population and demand for less invasive options.

Medicus aims to capture a significant portion of this market with SkinJect™, a dissolvable microneedle array (D-MNA) that delivers the well-established chemotherapeutic agent doxorubicin directly into the tumor. This innovative patch is designed to offer a patient-friendly alternative to surgery, potentially minimizing scarring and systemic side effects. In December 2025, the company successfully completed enrollment of 90 patients in its U.S.-based randomized, double-blind, placebo-controlled Phase 2 study (SKNJCT-003).

Anticipation for the topline results, expected in the first quarter of 2026, is high. Previously disclosed interim findings from the study were promising, demonstrating a clinical clearance rate greater than 60% in an exploratory analysis. While preliminary, these results, combined with a favorable safety profile, support the platform's potential. The company's collaboration with the Gorlin Syndrome Alliance to provide compassionate access to patients with multiple, inoperable BCCs further underscores the significant unmet need SkinJect™ aims to address.

An Accelerated Path to Market

To complement its clinical progress, Medicus is pursuing a sophisticated, multi-pronged regulatory strategy designed to accelerate SkinJect™'s path to market. The company has received positive feedback from the U.S. Food and Drug Administration (FDA) to utilize the 505(b)(2) regulatory pathway. This streamlined process allows Medicus to reference the FDA's prior findings on the safety and efficacy of doxorubicin, potentially saving years of development time and millions in costs.

Further bolstering this strategy, Medicus applied in November 2025 for the FDA Commissioner’s National Priority Voucher (CNPV) program. If granted, this voucher could dramatically shorten the FDA's review timeline for a future new drug application, a valuable asset that could be leveraged in a strategic partnership. The company’s de-risking efforts are also global, with full regulatory approvals secured in the United Kingdom to expand the Phase 2 study and a separate Phase 2 trial (SKNJCT-004) underway in the United Arab Emirates, with Cleveland Clinic Abu Dhabi as a principal investigator.

This comprehensive approach provides significant regulatory optionality and builds a robust data package, making SkinJect™ an increasingly attractive asset for potential out-licensing partners capable of steering it through large-scale commercialization.

A Diversified Pipeline Fueled by Acquisition and AI

While SkinJect™ is the near-term focus, Medicus has been aggressively expanding its therapeutic pipeline. The August 2025 acquisition of Antev Limited brought Teverelix, a next-generation GnRH antagonist, into the fold. Teverelix targets two substantial markets with an estimated combined value of $6 billion: advanced prostate cancer in patients with high cardiovascular risk and the prevention of acute urinary retention (AUR) recurrence.

Unlike some existing therapies, Teverelix is designed to suppress testosterone without an initial surge, potentially offering a safer profile for men with pre-existing heart conditions—a key differentiator in a competitive market. With FDA guidance already secured for its late-stage trial designs, Teverelix represents a mature, high-value asset that diversifies Medicus's clinical risk.

Underscoring its forward-looking strategy, Medicus is also integrating cutting-edge technology to enhance efficiency. In December 2025, it announced a letter of intent with Reliant AI Inc. to develop an AI-driven platform for optimizing clinical trials, starting with the upcoming Teverelix studies. This platform aims to improve clinical site selection, patient stratification, and enrollment forecasting, potentially making drug development faster and more capital-efficient. Furthermore, a memorandum of understanding with Helix Nanotechnologies explores combining Medicus's microneedle delivery system with HelixNano's advanced mRNA technology to create needle-free, thermostable vaccines—a visionary project that could revolutionize global vaccine distribution. As Medicus prepares to take the stage at Biotech Showcase, it presents a compelling narrative of a company at a crucial juncture, driven by imminent clinical data, strategic acquisitions, and a clear vision for building a next-generation biotech powerhouse.