Medicus Pharma Ltd. (NASDAQ: MDCX) lost ground Monday. The biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced the submission of a Rare Pediatric Disease Designation request to the U.S. Food and Drug Administration for SkinJect®, the Company’s investigational doxorubicin-containing microneedle array patch (D-MNA), for the treatment of basal cell carcinoma in patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome.
The RPDD submission was made pursuant to Section 529 of the Federal Food, Drug, and Cosmetic Act and follows the Company’s previously announced Orphan Drug Designation application (DRU-2026-11578), and Registrational study design (SKNJCT-005) which remains under FDA review.
The design of the Company’s Gorlin Syndrome development program has been informed through engagement with clinical experts and the Gorlin Syndrome Alliance, a patient advocacy group focused on the needs and priorities of this unique patient population.
“Patients with Gorlin Syndrome often face a lifetime of recurring surgeries and progressive treatment burden beginning at a young age,” said CEO Raza Bokhari, “SkinJect® is designed to provide localized treatment directly to the lesion and our recently concluded Phase 2 study has shown positive results, with 64% clinical clearance (CC) and 55% complete response.”
MDCX shares began Monday lower by 0.08 cents, or 2.3%, to 33 cents.
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