Medicus Pharma (NASDAQ:MDCX) announced that it has submitted Protocol SKNJCT-005 to the US Food and Drug Administration (FDA) under its existing Investigational New Drug (IND) application for SkinJect, advancing the therapy into registrational development for patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome (NBCCS). The company said the protocol outlines a Phase 2b, open-label study intended to generate efficacy and safety data that could support a future New Drug Application (NDA) for SkinJect in the rare inherited disorder.
Medicus Pharma advances SkinJect program with FDA submission targeting Gorlin Syndrome
Source: Proactive Investors