Medicus Pharma stock jumps after FDA priority voucher application
Investing.com -- Medicus Pharma Ltd (NASDAQ:MDCX) stock surged 11.4% Monday after the company submitted an FDA Commissioner’s national priority voucher application for its skin cancer treatment.
The biotech firm’s application is for its SKNJCT-003 program, which is evaluating a Doxorubicin Microneedle Array to non-invasively treat basal cell carcinoma (BCC) of the skin. The submission includes a statement outlining how the treatment aligns with FDA national priorities in cancer care access, affordability, and rare-disease needs.
The FDA’s Commissioner’s National Priority Voucher (CPNV) program, announced in June 2025, offers an expedited review process that could shorten the typical 10-12 month review time to just 1-2 months. The agency plans to issue a limited number of these vouchers to companies aligned with U.S. national health priorities.
Medicus believes its microneedle patch technology addresses a significant public health need as BCC is the most common cancer in the United States, with over five million new cases annually. The company’s biodegradable patch delivers treatment directly to lesions without requiring surgery, potentially offering a more accessible alternative to the current standard of Mohs micrographic surgery.
The company is currently conducting a Phase 2 clinical study across nine U.S. sites, with an interim analysis showing more than 60% clinical clearance. Medicus has also expanded its clinical trials to the United Arab Emirates and received regulatory approvals in the United Kingdom.
The treatment could be particularly impactful for patients with Gorlin syndrome, a rare genetic disorder where individuals develop hundreds of recurring BCCs throughout their lifetime. In October, Medicus announced a collaboration with the Gorlin Syndrome Alliance to pursue expanded access to the treatment for these patients.
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