Medicus Pharma (Nasdaq: MDCX) Nears Surgery-Free Breakthrough in Oncology

Skin cancer is rarely viewed as life-changing, but for millions of patients each year, basal cell carcinoma brings a cycle of surgeries, scars, and slow recovery that feels endless. Hospitals are overloaded, dermatologists are booked months in advance, and treatments that remove tumors often leave lasting damage. The challenge is not identifying the cancer; it is finding a way to treat it without cutting the patient open. That is the gap Medicus Pharma Ltd. (Nasdaq: MDCX) is working to close.

SkinJect: Redefining Local Cancer Therapy

The company's dissolvable microneedle array, known as SkinJect, represents a quiet revolution in oncology. Instead of scalpels or radiation, the patch delivers doxorubicin directly into the lesion through microscopic needles that dissolve after use. This approach, now advancing through an FDA-cleared 505(b)(2) pathway, could redefine the standard of care for basal cell carcinoma, a market valued at roughly two billion dollars.

In its ongoing Phase 2 SKNJCT-003 trial across nine U.S. sites, Medicus has already enrolled more than seventy-five percent of its target population. Interim data released earlier this year showed over sixty percent clearance after just one or two applications. These are not theoretical results-they are evidence that a skin patch may soon rival surgery itself.

In September, the FDA provided what Medicus called "positive and constructive feedback" during its Type C meeting, confirming that the company's proposed study design, patient criteria, and endpoints align with regulatory expectations. The agency also offered guidance on optimizing the microneedle formulation, adhesive layer, and applicator system for upcoming pivotal studies.

"Establishing 505(b)(2) as a regulatory pathway to bring to market our novel, non-invasive SkinJect D-MNA treatment to cure BCC of the skin is a game changer," said Executive Chairman and CEO Dr. Raza Bokhari. "By leveraging existing doxorubicin safety data, we will not only realize substantial drug development cost savings but also time savings compared to a traditional full development program." Medicus expects to complete enrollment for SKNJCT-003 before the end of 2025 and hold its End-of-Phase 2 meeting with the FDA in early 2026, positioning the product for potential commercial readiness in 2027.

Global Expansion: SKNJCT-004 in the UAE

Momentum is not confined to the United States. A parallel Phase 2 study, SKNJCT-004, is underway in the United Arab Emirates across six hospitals, including Cleveland Clinic Abu Dhabi and Sheikh Shakhbout Medical City. Coordinated by Insights Research Organization and Solutions, a portfolio company of M42, the UAE trial is expanding Medicus's global clinical footprint and reinforcing the cross-border appeal of non-invasive oncology care.

Building a Broader Pipeline: Teverelix

The company's growth story does not stop at skin cancer. In August, Medicus completed its acquisition of Antev, a United Kingdom-based biotechnology firm developing Teverelix, a next-generation gonadotrophin-releasing hormone antagonist for prostate cancer and acute urinary retention. Teverelix works differently from existing therapies that can cause testosterone surges and cardiovascular stress. Instead, it suppresses sex hormone production directly, avoiding those spikes and potentially reducing risk for patients with existing heart conditions. Formulated as a microcrystalline suspension with a six-week dosing interval, Teverelix offers a long-acting profile that may improve compliance and outcomes.

For Medicus Pharma Ltd. (Nasdaq: MDCX), this acquisition expands the company's reach into two multibillion-dollar markets while building a more diversified late-stage pipeline. Advanced prostate cancer treatments generate roughly four billion dollars annually, while therapies for acute urinary retention approach another two billion. By integrating Teverelix alongside SkinJect, Medicus is positioning itself as a clinical-stage platform company focused on replacing invasive, hospital-bound procedures with precision, patient-friendly therapeutics.

The Trajectory Ahead

The trajectory is clear. One program targets the most common skin cancer on earth, with a regulatory pathway designed for speed. The other brings a novel therapy for prostate disease and urinary complications with fewer cardiovascular risks and longer dosing intervals. Together they represent a vision of care that is more efficient, less painful, and closer to what patients actually want.

Medicus Pharma Ltd. (Nasdaq: MDCX) is not chasing the next incremental advance. It is designing a new model for how serious conditions can be treated-without scalpels, without hospital beds, and with proof that innovation can heal as well as it disrupts.

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