Medicus Pharma gets FDA clearance to start Gorlin Syndrome study

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

July 27, 2026 8:17 AM EDT

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... More