Medicus Pharma Ltd. (MDCX) on Monday said it has submitted a request to the U.S. Food and Drug Administration for Rare Pediatric Disease Designation for SkinJect, its investigational microneedle patch for the treatment of basal cell carcinoma in patients with Gorlin Syndrome.
SkinJect is a dissolvable microneedle array patch designed to deliver doxorubicin directly into basal cell carcinoma lesions.
The submission follows the company's previously announced application for Orphan Drug Designation and its proposed registrational study design, both of which remain under FDA review.
Medicus said results from a recently completed Phase 2 study showed that the 200-microgram SkinJect treatment achieved clinical clearance in 64% of evaluable nodular basal cell carcinoma patients and a complete response rate of 55%, while maintaining a favorable safety and tolerability profile.
Gorlin Syndrome is a rare genetic disorder that can cause patients to develop numerous basal cell carcinomas throughout their lives, often beginning in childhood or adolescence.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.