{"id":984960,"date":"2026-07-27T08:24:33","date_gmt":"2026-07-27T12:24:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/medicus-pharma-receives-fda-study-may-proceed-letter-for-nda-enabling-registrational-skinject-study-in-patients-with-gorlin-syndrome\/"},"modified":"2026-07-27T08:24:33","modified_gmt":"2026-07-27T12:24:33","slug":"medicus-pharma-receives-fda-study-may-proceed-letter-for-nda-enabling-registrational-skinject-study-in-patients-with-gorlin-syndrome","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/medicus-pharma-receives-fda-study-may-proceed-letter-for-nda-enabling-registrational-skinject-study-in-patients-with-gorlin-syndrome\/","title":{"rendered":"Medicus Pharma Receives FDA \u201cStudy May Proceed\u201d Letter for NDA-Enabling Registrational\u00a0SkinJect\u00ae Study in Patients with Gorlin Syndrome"},"content":{"rendered":"

\nSKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up
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PHILADELPHIA, July 27, 2026 (GLOBE NEWSWIRE) — Medicus Pharma Ltd. (NASDAQ: MDCX) (\u201cMedicus\u201d or the \u201cCompany\u201d), 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 (\u201cFDA\u201d) has completed its safety review of the Company’s Investigational New Drug (“IND”) application for SKNJCT-005 and issued a\u00a0“Study May Proceed”<\/strong>\u00a0letter authorizing the initiation of the Company’s NDA-enabling registrational Phase 2b clinical study evaluating SkinJect\u00ae (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas (“BCCs”).<\/p>\n

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.<\/p>\n

\n \u201cReceiving FDA clearance to initiate our registrational Gorlin Syndrome study represents a significant regulatory milestone for the SkinJect<\/em>\u00ae program,\u201d\u00a0<\/em>stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO<\/em><\/strong>.\u00a0“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\u00ae 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.”<\/em><\/p>\n

\n FDA Authorization Advances Registrational Development<\/strong>\n <\/p>\n

SKNJCT-005 is designed as a\u00a0Phase 2b, open-label, multicenter, NDA-enabling registrational study<\/strong>\u00a0evaluating SkinJect\u00ae 200 mcg in patients with\u00a0Gorlin Syndrome (Nevoid Basal Cell Carcinoma Syndrome)<\/strong>\u00a0who develop multiple basal cell carcinomas requiring repeated surgical treatment. The study is intended to generate robust efficacy and safety data to support registration of SkinJect\u00ae in this rare disease population and is expected to enroll up to 50 patients.<\/p>\n

SkinJect\u00ae is a proprietary dissolvable microneedle-array patch that delivers doxorubicin directly into basal cell carcinoma lesions, enabling localized treatment while minimizing systemic drug exposure. Previous Phase 1 and Phase 2 studies have demonstrated a favorable safety profile together with encouraging clinical and histological clearance rates in patients with basal cell carcinoma. The submitted protocol cites data from the completed 90-patient SKNJCT-003 study demonstrating\u00a064% clinical clearance and 55% histological clearance<\/strong>\u00a0following three treatments with the 200-mcg dose at Day 57.\u00a0<\/p>\n

\n Protocol Strengthened Following FDA Review<\/strong>\n <\/p>\n

As part of the FDA review process, the Agency provided constructive recommendations designed to enhance the scientific and regulatory utility of the study. Medicus agreed to incorporate these recommendations through a protocol amendment, including:<\/p>\n