SkinJect (D-MNA/Doxorubicin) - (SKNJCT-005)

July 27, 2026: Medicus Pharma Ltd. (NASDAQ: MDCX) said the FDA completed its safety review of the IND for SKNJCT-005 and issued a “Study May Proceed” letter (dated July 23, 2026), authorizing initiation of an NDA-enabling registrational Phase 2b trial of SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome (nevoid basal cell carcinoma syndrome) who have multiple basal cell carcinomas. The open-label, multicenter study is expected to enroll up to 50 patients.

Following FDA feedback (including June 18, 2026 information requests), Medicus will amend the protocol to add baseline biopsy confirmation of nodular BCC, revise the primary endpoint to require both clinical and histological clearance at a prespecified time point, require in-person investigator assessment plus histology, align the responder definition, and extend follow-up from 24 weeks to at least two years for durability. The FDA also made non-hold recommendations (e.g., PK assessments, DSMB, statistical methodology/SAP, and future randomized/blinded comparator designs), which Medicus is evaluating.

The protocol cites prior SKNJCT-003 data (90 patients) showing 64% clinical clearance and 55% histological clearance at Day 57 after three 200-mcg treatments. The company said it will provide future updates on study initiation and enrollment timing.