Medicus Pharma Ltd. (NASDAQ: MDCX) announced that the U.S. Food and Drug Administration has issued a "Study May Proceed" letter for the company's SKNJCT-005 registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome who present with multiple basal cell carcinomas.

The FDA completed its safety review of the company's Investigational New Drug application and issued the letter on July 23, 2026, following Medicus' submission of the SKNJCT-005 protocol and its response to the agency's June 18, 2026, information requests.

The Phase 2b open-label, multicenter study is designed to enroll up to 50 patients and is intended to support a New Drug Application for SkinJect®. The protocol incorporates several FDA recommendations, including baseline biopsy confirmation of nodular basal cell carcinoma, a revised primary efficacy endpoint requiring both clinical and histological clearance, in-person investigator assessment, and an extension of patient follow-up from 24 weeks to at least two years.

The FDA also provided additional recommendations related to pharmacokinetic assessments, genetic confirmation of Gorlin Syndrome, establishment of an independent Data Safety Monitoring Board, and statistical methodology refinements. The agency identified these as not constituting clinical hold issues. Medicus said it intends to submit an amended protocol incorporating those recommendations.

SkinJect® is a dissolvable microneedle-array patch that delivers doxorubicin directly into basal cell carcinoma lesions. Data from the completed 90-patient SKNJCT-003 study showed 64% clinical clearance and 55% histological clearance following three treatments with the 200-mcg dose at Day 57.

Gorlin Syndrome is a rare genetic disorder estimated to affect approximately 1 in 30,000 to 60,000 individuals worldwide, corresponding to an estimated U.S. patient population of 6,000 to 12,000. Affected individuals may develop dozens to more than 1,000 basal cell carcinomas during their lifetime.

The company said it expects to provide additional updates on study initiation and enrollment timing as development progresses.