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Medicus Pharma (NASDAQ: MDCX) has received Minor Use in Major Species (MUMS) Designation from the FDA for its Doxorubicin-containing microneedle array (D-MNA) patch to treat external squamous cell carcinoma (SCC) in horses. The MUMS status, similar to Orphan Drug designation for human drugs, grants a 7-year exclusive marketing period post-approval.
The D-MNA is a patent-protected dissolvable transdermal patch using cellulose-based microneedles loaded with doxorubicin to penetrate and treat skin tumors. The company plans to target the equine SCC market, which affects 2-3% of the US horse population of 6.6-7.25 million horses, particularly in breeds with white or partially white coats. Medicus aims to have a commercially viable product by 2026.
Medicus Pharma (NASDAQ: MDCX) announced a collaboration with Swanielle to expand its Phase 2 clinical study for Basal Cell Carcinoma (BCC) treatment in the Asia-Pacific region. The ongoing Phase 2 study (SKNJCT-003) has already enrolled 25% of the targeted 60 patients across nine U.S. clinical sites. The company plans an interim data analysis in Q1 2025 and FDA Type C meeting in Q2 2025. The study evaluates two dose levels of D-MNA against placebo, building on successful Phase 1 results that showed complete responses in 6 participants with no serious adverse events.
Medicus Pharma announces key leadership changes with the appointment of Faisal Mehmud, MD as Chief Medical Officer and the promotion of Edward Brennan, MD to Chief Scientific Officer & Head of R&D. Dr. Mehmud brings over 20 years of global pharmaceutical experience from companies like GSK, Pfizer, and BMS. The company is developing a novel dissolvable doxorubicin-containing microneedle array (D-MNA) to treat non-melanoma skin cancer. Their Phase 1 study completed in March 2021 showed safety and tolerability, with six participants achieving complete response. A Phase 2 clinical trial is currently recruiting 60 patients across nine U.S. sites to evaluate two dose levels against placebo.
Medicus Pharma (NASDAQ: MDCX) announced the closing of its US$4.0M initial public offering in the United States, consisting of 970,000 units at US$4.125 per unit. Each unit includes one common share and one warrant with a US$4.64 exercise price, expiring in 5 years. The company's shares and warrants began trading on Nasdaq under 'MDCX' and 'MDCXW'. The proceeds will fund Phase 2 clinical trials for basal cell carcinoma treatment using their doxorubicin microarray needle skinpatch, with potential expansion to other non-melanoma skin diseases. The underwriter exercised an overallotment option for 145,500 additional warrants.
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