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Medicus Pharma Receives FDA's Study May Proceed Letter Authorization For Its Investigational New Drug For SKNJCT-005 To Start Phase 2b Clinical Study To Treat Gorlin Syndrome
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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.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.
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