Medicus Pharma cleared by FDA for registrational Phase 2b trial in patients with Gorlin Syndrome
Yahoo Finance · Jul 27, 2026 · Medicus Pharma Ltd. Warrant (MDCXW)
Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA), authorizing the start of its NDA-enabling Phase 2b clinical trial for SkinJect® in patients with Gorlin Syndrome. The FDA clearance follows the company's submission of the SKNJCT-005 study protocol and its response to the agency's June 2026 information requests, completing the safety review of the Investigational New Drug (IND) application. The Phase 2b, open-label, multicenter trial will evaluate SkinJect® 200 mcg in up to 50 patients with Gorlin Syndrome who develop multiple basal cell carcinomas (BCCs) requiring repeated surgical treatment. The study is designed to generate the efficacy and safety data needed to support a future New Drug Application (NDA). Gorlin Syndrome is a rare inherited genetic disorder linked to abnormalities in the Hedgehog signaling pathway, causing patients to develop numero
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