MDCX News & Events

Medicus Pharma announced the submission of Protocol SKNJCT-005 to the FDA under the company's existing investigational new drug, or IND, application, for SkinJect into registrational development for patients with Gorlin Syndrome, also called Nevoid Basal Cell Carcinoma Syndrome. The submitted protocol outlines a Phase 2b, open-label study designed to generate efficacy and safety data intended to support a future new drug application for SkinJect in Gorlin Syndrome.

"During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect data, advancement of Teverelix into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives," stated Raza Bokhari, Medicus' Executive Chairman & CEO. "We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond."

Medicus Pharma announced results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of doxorubicin microneedle Array to treat nodular basal cell carcinoma of the skin. The expanded central pathology-verified efficacy analysis of 69 participants showed a progressive, dose-dependent improvement, with the 200microgram cohort achieving the highest clinical and histological clearance rates by day 57 vs. device-only control. The company said the dataset, which also confirmed a favorable safety and tolerability profile without drug-related serious adverse events or systemic doxorubicin toxicity, supports a registrational path and planned end-of-Phase 2 discussions with the FDA. "We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program," said Raza Bokhari, chairman and CEO of Medicus.