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ABU DHABI - Medicus Pharma Ltd. (NASDAQ:MDCX), a $48.7 million market cap biotechnology company, has enrolled the first patient in its United Arab Emirates phase 2 clinical study testing a non-invasive treatment for basal cell carcinoma (BCC) of the skin, according to a company press release. InvestingPro data shows analysts maintain a strong buy consensus with price targets ranging from $20 to $27.
The SKNJCT-004 study aims to randomize 36 patients across six UAE medical centers, including Cleveland Clinic Abu Dhabi, which serves as the principal investigator site. The trial will evaluate two dose levels of dissolvable Doxorubicin-containing microneedle arrays (D-MNA) compared to a placebo control.
The randomized, double-blind study will divide participants into three equal groups: one receiving placebo microneedle arrays, another receiving 100μg of D-MNA, and a third receiving 200μg of D-MNA.
Medicus is simultaneously conducting a similar phase 2 study (SKNJCT-003) in the United States and Europe, which began in August 2024. That study has been expanded to include 90 participants, with more than 75% already randomized.
In March 2025, Medicus reported preliminary results from an interim analysis of the SKNJCT-003 study, indicating more than 60% clinical clearance after randomizing over half of the initially targeted 60 patients.
The company received positive feedback from the FDA in September 2025 regarding its development pathway for the skin cancer treatment.
Medicus recently completed the acquisition of UK-based Antev in August 2025, adding Teverelix, a GnRH antagonist being developed for prostate cancer patients with cardiovascular risks and those with acute urinary retention.
The information in this article is based on a company press release.
In other recent news, Medicus Pharma Ltd. has received approval from the U.S. Food and Drug Administration to pursue the 505(b)(2) regulatory pathway for its Skinject product, a treatment for basal cell carcinoma (BCC). This pathway allows the company to use existing doxorubicin safety data, potentially streamlining the development process. Additionally, Medicus Pharma has started recruiting patients for its SKNJCT-004 phase 2 clinical study at Cleveland Clinic Abu Dhabi, focusing on a non-invasive treatment using a dissolvable microneedle patch. The study has been approved by the UAE Department of Health. In another development, the FDA has accepted Medicus Pharma’s Type C meeting request regarding its D-MNA skin cancer treatment program, with a response expected by the end of Q3 2025. The company’s SKNJCT-003 Phase 2 clinical study has also progressed, having randomized over 75% of the planned 90 participants. Furthermore, Medicus Pharma has appointed Deloitte LLP as its exclusive lead financial adviser to explore potential out-licensing opportunities for its D-MNA treatment, formalizing the partnership in late July.
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