Medicus Pharma Ltd（MDCX）资讯与事件MDCXMedicus Pharma Ltd

Medicus Advances Clinical Platforms in Q2 2026

"The second quarter of 2026 marked a defining period for Medicus as we successfully advanced both of our lead therapeutic platforms into their next stages of clinical and regulatory development, while strengthening our balance sheet and financial flexibility," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "We believe Medicus is well positioned with two differentiated programs advancing towards late-stage development, each addressing significant commercial opportunities through distinct regulatory pathways and multiple anticipated value-creating milestones. We remain focused on disciplined execution, regulatory excellence and strategic growth as we continue building long-term shareholder value."

Medicus Pharma Receives FDA Approval for SKNJCT-005 to Enter Phase 2b Clinical Trial

Medicus Pharma announced the FDA has completed its safety review of the company's Investigational New Drug application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the company's NDA-enabling registrational Phase 2b study evaluating SkinJect 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas. The authorization follows Medicus' submission of the SKNJCT-005 protocol and the company's response to the FDA's June 18 information requests. SKNJCT-005 is designed as a Phase 2b, open-label, multicenter study expected to enroll up to 50 patients. SkinJect is a dissolvable microneedle-array patch that delivers doxorubicin directly into basal cell carcinoma lesions. The submitted protocol cites data from the completed 90-patient SKNJCT-003 study demonstrating 64% clinical clearance and 55% histological clearance following three treatments with the 200 mcg dose at Day 57. As part of the FDA review process, Medicus agreed to incorporate recommendations through a protocol amendment, including baseline biopsy confirmation of nodular basal cell carcinoma, a revised primary efficacy endpoint requiring both clinical and histological clearance at a prespecified time point, and extending patient follow-up from 24 weeks to at least two years to evaluate durability of response.

Medicus Pharma Receives FDA Approval for Teverelix Clinical Study

Medicus Pharma announced that it has received written feedback from the FDA and central Institutional Review Board, or IRB, approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention. The randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, is a novel study designed to evaluate the pharmacodynamic effects of Teverelix DP, a long-acting gonadotropin-releasing hormone antagonist, on prostate volume and urinary function in men following a first episode of AUR. The company submitted the optimized protocol to the FDA on April 2, under its existing investigational new drug application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.