MDCX News & Events

Medicus Pharma announced the submission of a Rare Pediatric Disease Designation request to the FDA for SkinJect, the company's investigational doxorubicin-containing microneedle array patch, for the treatment of basal cell carcinoma in patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome.

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."