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PHILADELPHIA - Medicus Pharma Ltd. (NASDAQ: MDCX), a small-cap pharmaceutical company with a market capitalization of $32.37 million, has submitted a comprehensive product development plan for a novel treatment of equine squamous cell carcinoma (SCC), a common skin cancer in horses. The plan, under the Investigational New Animal Drug (INAD) designation, aims to gain concurrence from the FDA to use the company’s Doxorubicin-containing microneedle array (D-MNA) patch, which was granted a Minor Use in Major Species (MUMS) designation in December 2024.
The MUMS designation, akin to the Orphan Drug status in human medicine, could provide Medicus with an exclusive seven-year marketing period post-approval, subject to meeting all requirements. The D-MNA patch is designed to deliver the chemotherapy agent doxorubicin directly into the tumor via dissolvable microneedles, potentially offering a non-invasive alternative to current treatments that often involve surgery and topical chemotherapy.
The company’s CEO, Dr. Raza Bokhari, highlighted the limited options in veterinary oncology and the significant market potential for the D-MNA patch, which is estimated to be around $250 million. According to InvestingPro analysis, while the company shows promise in its development pipeline, it currently faces challenges with weak gross profit margins. Subscribers to InvestingPro can access detailed financial health metrics and 5 additional expert insights about MDCX’s potential. The product development plan includes a randomized, double-blind, placebo-controlled study enrolling up to 50 horses to assess the efficacy of two dose levels of D-MNA compared to a placebo control over six months.
Medicus Pharma’s previous human clinical trial, SKNJCT-001, indicated safety and tolerability of the D-MNA patch, with no serious adverse events reported and complete responses observed in some participants. The company is also conducting a Phase 2 clinical study, SKNJCT-003, in the United States and Europe, with interim analysis showing positive trends.
Additionally, the company has initiated another study, SKNJCT-004, in the United Arab Emirates and has announced plans to acquire Antev Ltd., a UK-based biotech firm developing a treatment for prostate cancer. The stock has shown recent momentum with a 4.94% gain over the past week, though it remains significantly below its 52-week high of $8.94. Analysts maintain an optimistic outlook, with price targets ranging from $5.61 to $27, according to InvestingPro data.
This news is based on a press release statement and reflects the company’s current endeavors in advancing its cancer treatment portfolio for both human and veterinary medicine. The potential acquisition of Antev and its implications for Medicus Pharma’s future offerings remain subject to successful due diligence and regulatory approvals.
In other recent news, Medicus Pharma Ltd. has completed a $7 million public offering, selling 2,260,000 units at $3.10 each. The funds are aimed at advancing their Phase 2 trial for a basal cell carcinoma treatment, with potential expansion into other non-melanoma skin disease studies. The company also announced plans to acquire UK-based Antev Ltd., contingent on due diligence and regulatory approvals. This acquisition is valued at approximately $75 million and includes contingent payments of up to $65 million for future FDA approvals. Boral Capital has raised Medicus Pharma’s stock target from $14.00 to $27.00, maintaining a Buy rating, following the announcement of the Antev acquisition. Additionally, Medicus Pharma has expanded its Phase 2 clinical trial for a basal cell carcinoma treatment, increasing patient enrollment from sixty to ninety. The company has also canceled its previously scheduled annual and special meeting of shareholders, with no further details provided. These developments indicate significant strategic moves by Medicus Pharma in expanding its clinical and therapeutic portfolio.
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