Nov. 17 at 6:29 PM
Medicus Pharma shares rose Monday after the company submitted a request for a National Priority Voucher from the FDA Commissioner for its skin-cancer treatment. The application covers its SKNJCT-003 program, which uses a doxorubicin microneedle array to non-invasively treat basal cell carcinoma. The filing outlines how the therapy aligns with the FDA’s national priorities in cancer care access, affordability, and rare-disease needs.
The FDA’s new Commissioner’s Priority National Voucher program, launched in June 2025, offers an accelerated review process that can shorten approval timelines from 10–12 months to just 1–2 months.
Medicus says its biodegradable microneedle patch addresses a major public-health need, offering a non-surgical alternative to Mohs surgery for the over five million annual U.S. BCC cases. The company is running a Phase 2 trial at nine U.S. sites, with interim results showing over 60% clinical clearance, and has expanded studies to the UAE.
$MDCX