Medicus Pharma wins FDA clearance to start SkinJect registrational Gorlin syndrome trial

Reuters2026/07/27 12:17

By:Reuters

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Medicus received an FDA “study may proceed” letter, clearing its SKNJCT-005 Phase 2b registrational trial of SkinJect in Gorlin syndrome.
The open-label, multicenter study targets up to 50 patients with multiple basal cell carcinomas; results are intended to support a potential NDA filing.
The FDA review prompted protocol changes, including biopsy confirmation, a composite clinical-plus-histological clearance endpoint, and follow-up extended to at least two years.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Medicus Pharma Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607270817PRIMZONEFULLFEED9768001) on July 27, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Medicus Pharma wins FDA clearance to start SkinJect registrational Gorlin syndrome trial

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