Medicus Pharma Ltd. Announces Filing of FDA Commissioner's National Priority Voucher Application (CNPV) for SKNJCT-003 to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin

SKNJCT-003 Doxorubicin containing Microneedle Array (D-MNA) clinical development program to non-invasively treat BCC aligns with national priorities of public health impact, unmet medical need, access, affordability, domestic manufacturing and rare-disease alignment.

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 17, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that it has submitted an FDA Commissioner's national priority voucher (CNPV) application on behalf of Skinject (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The submission includes a complete Statement of Interest outlining SkinJect's alignment with FDA national priorities in cancer care access, affordability, and rare-disease needs.

On June 17, 2025, FDA Commissioner Marty Makary, MD, MPH announced a new approval pathway, the Commissioner's National Priority Voucher (CPNV)for approval of drugs to enhance the health interests of Americans. Previously, on May 25 he identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority. The new voucher may be redeemed by drug developers to participate in a commissioner-led program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission. The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.

The FDA plans, in the first year of the program, to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of addressing a health crisis in the U.S., delivering more innovative cures for the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue.