Medicus Pharma Ltd. Gains FDA Support for Skinject Development

Medicus Pharma Ltd. has received positive feedback from the FDA regarding its Skinject treatment for basal cell carcinoma (BCC) of the skin. This advancement follows a Type C meeting that outlined the 505(b)(2) regulatory pathway for its dissolvable Doxorubicin-containing microneedle arrays (D-MNA). The FDA affirmed the potential of this novel approach, which could capture a $2 billion market opportunity.

The agency provided detailed feedback on clinical trial design, including patient population and safety assessments, enhancing the company’s clinical strategy for Skinject. Medicus aims to complete patient recruitment for their current Phase 2 trial, SKNJCT-003, by the end of 2025, with an anticipated FDA submission in early 2026.

The company is actively conducting studies both in the United States and the United Arab Emirates. Additionally, Medicus has completed the acquisition of Antev, advancing its product pipeline with Teverelix, a GnRH antagonist aimed at treating advanced prostate cancer.