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Medicus Pharma Ltd. Receives Positive Feedback From the Food and Drug Adminstration (FDA) Type C Meeting Supporting the Development of Skinject
The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"The FDA agrees that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat basal cell carcinoma (BCC) of the skin using dissolvable Doxorubicin-containing Microneedle arrays (D-MNA) representing ~$2 billion in potential market opportunityThe Company plans to complete patient recruitment for SKNJCT-003 before the end of Q4 2025 and to request End-of-Phase 2 (EOP2) with the FDA in Q1 2026 PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 29, 2025 / 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 therapeutics assets, is pleased to announce positive feedback from Type C meeting with United States Food and Drug Administration (FDA).The purpose of the Type C meeting was to discuss the design, endpoints, and other key protocol elements for the clinical development of doxorubicin containing microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.The FDA provided clarity and further alignment that a relative bioavailability study with the Company's D-MNA product to treat BCC administered under certain conditions could provide support towards establishing a clinical bridge for the 505(b)(2) regulatory pathway as well as help satisfy the bioavailability requirement of the Company's D-MNA product as stated in 21CFR320.21. More specifically, the FDA provided positive and constructive feedback on a number of topics for the continued development of Skinject including, but not limited to: the appropriate primary endpoint for the next study; proposed patient population definition, including tumor size limits, location restrictions, and histological confirmation requirements; proposed randomized, double-blind, placebo-controlled, study design for future studies that are intended to demonstrate the effectiveness of D-MNA in treating BCC; and current safety assessments for the proposed study.In anticipation of future pivotal studies, the FDA also provided recommendations to continue to optimize formulation and microneedle design, integrate an adhesive layer to affix the microneedle system to the body, and incorporate the use of an applicator to consistently apply the product to the application site.\"Establishing 505(b)(2) as a regulatory pathway t...