Core Insights - The FDA has approved the Company to pursue the 505(b)(2) regulatory pathway for a non-invasive treatment of basal cell carcinoma (BCC) using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) [1] - The potential market opportunity for this treatment is estimated at approximately $2 billion [1] - The Company aims to complete patient recruitment for the SKNJCT-003 trial by the end of Q4 2025 and plans to request End-of-Phase 2 (EOP2) with the FDA in Q1 2026 [1] Company Developments - Medicus Pharma Ltd. is focused on advancing clinical development programs for novel and potentially disruptive therapeutic assets [1] - Positive feedback was received from a Type C meeting with the FDA, indicating a favorable regulatory outlook for the Company's product [1]
Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject