08:41 AM EDT, 07/27/2026 (MT Newswires) -- Medicus Pharma ( MDCX ) said Monday that the US Food and Drug Administration issued a "Study May Proceed" letter for its Investigational New Drug application, allowing the company to begin an NDA-enabling Phase 2b SkinJect study in patients with Gorlin Syndrome.

The SKNJCT-005 study will evaluate SkinJect 200 mcg in up to 50 Gorlin Syndrome patients with multiple basal cell carcinomas requiring repeated surgical treatment, the company said.

Medicus said the FDA recommended protocol enhancements, including revised efficacy assessments, baseline biopsy requirements and extended follow-up of at least two years to evaluate durability of response.

SkinJect delivers doxorubicin directly into lesions through a dissolvable microneedle patch, and Medicus plans to provide updates on study initiation and enrollment, it added.