SkinJect (D-MNA/Doxorubicin) - (SKNJCT-005)

June 15, 2026: Medicus Pharma Ltd. (NASDAQ: MDCX) announced it submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for SkinJect® (investigational doxorubicin-containing microneedle array patch; D‑MNA) to treat basal cell carcinoma (BCC) in patients with Gorlin Syndrome (nevoid basal cell carcinoma syndrome). The RPDD request follows a previously announced Orphan Drug Designation application (DRU‑2026‑11578) and a registrational study design (SKNJCT‑005) that remains under FDA review.

Medicus cited results from a recently completed Phase 2 study in nodular BCC in which the 200 µg D‑MNA arm showed 64% clinical clearance and 55% histological clearance among evaluable patients, with a favorable safety and tolerability profile.

If RPDD is granted and a future marketing application is approved for the designated indication, SkinJect® could be eligible for a Rare Pediatric Disease Priority Review Voucher. If Orphan Drug Designation is granted and a future marketing application is approved, SkinJect® could receive seven years of U.S. market exclusivity and other incentives.