Medicus Pharma Ltd. has finished enrolling 90 patients in its Phase 2 SKNJCT‑003 study, which evaluates a non‑invasive doxorubicin microneedle array (D‑MNA) for basal cell carcinoma (BCC). The trial, conducted at nine U.S. clinical sites, reached its target ahead of schedule, positioning the company to deliver topline data in the first quarter of 2026.
The D‑MNA platform delivers doxorubicin directly to skin tumors via a dissolvable microneedle patch, aiming to provide a localized, patient‑friendly alternative to surgical excision or topical therapies. In early Phase 1 work, the company reported six complete histologic responses among 13 participants and a 60 % clinical clearance rate in 26 patients during a Q1 2025 interim analysis.
Medicus estimates the market opportunity for its skin‑cancer platform at roughly $2 billion, driven by the high prevalence of BCC in the United States. The company’s CEO, Dr. Raza Bokhari, emphasized that completing enrollment brings the program closer to a potential 505(b)(2) regulatory pathway and an FDA End‑of‑Phase 2 meeting slated for the first half of 2026.
The company has also secured regulatory and ethical approvals to expand the trial into the United Kingdom, with approvals received in November 2025. This international expansion broadens the patient pool and strengthens the evidence base for the D‑MNA platform.
While the enrollment milestone is a positive development, Medicus remains a pre‑revenue, loss‑making entity. The company’s financial statements show no revenue and significant operating losses, underscoring the need for continued capital raising and disciplined spending as it advances the pipeline.
The upcoming Phase 2 results will be a key indicator of the D‑MNA’s clinical efficacy and safety profile. Positive data could de‑risk the asset, attract strategic partnerships, and potentially unlock a sizable market share in the BCC treatment space.
Management remains focused on maintaining the clinical development timeline while managing cash burn. The company’s recent UK expansion and planned FDA engagement signal confidence in the platform’s potential, but investors will continue to monitor the company’s financial resilience as it progresses toward commercialization.
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