Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

About this update from Medicus Pharma Ltd.

SKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up PHILADELPHIA, July 27, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced that the U.S. Food and Drug Administration ("FDA") has completed its safety review of the Company's Investigational New Drug ("IND") application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas ("BCCs"). The FDA authorization follows Medicus' submission of the SKNJCT-005 protocol and the Company's comprehensive response to the Agency's June 18, 2026, information requests. "Receiving FDA clearance to initiate our registrational Gorlin Syndrome study represents a significant regulatory milestone for the SkinJect® program," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "Importantly, the FDA's recommendations strengthen the registrational study by enhancing the scientific rigor of the efficacy assessments while further supporting the long-term evaluation of treatment durability. We believe these refinements position SkinJect® to generate an even more robust data package as we advance toward a potential NDA submission for patients with Gorlin Syndrome, a population with substantial unmet medical need, who frequently face repeated surgeries throughout their lifetimes. The ability to treat multiple lesions using a localized precision therapy represents an important advancement and what we believe could become a new standard of care for this patient population." FDA Authorization Advances Registrational Development SKNJCT-005 is designed as a Phase 2b, open-label, multicenter, NDA-enabling registrational study evaluating SkinJect® 200 mcg in patients with Gorlin Syndrome (Nevoid Basal Cell Carcinoma Syndrome) who develop multiple basal cell carcinomas requiring repeated surgical treatment. The study is intended to gen...

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