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PHILADELPHIA – Medicus Pharma Ltd. (NASDAQ: MDCX), a biotech company with a market capitalization of $46.91 million and an impressive 64.61% year-to-date return according to InvestingPro, announced today the expansion of its phase 2 clinical trial for a non-invasive basal cell carcinoma (BCC) treatment, following approval from the Institutional Review Board (IRB). The study, identified as SKNJCT-003, will now include ninety patients, up from the initial sixty, and extend into additional clinical sites in the United States and Europe.
The company has successfully randomized over forty-five participants thus far and aims to meet with the U.S. Food and Drug Administration (FDA) for a Type C meeting before the end of Q2 2025. This meeting is expected to discuss the study’s progress and future steps.
Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, highlighted the timeliness of the expansion, which coincides with the company’s efforts to gain global validation for its novel treatment approach. The treatment utilizes a microneedle patch to deliver a chemotherapeutic agent directly to tumor cells.
Preliminary results from an interim analysis conducted in March 2025 indicated that more than 60% of subjects showed complete clinical clearance of BCC. With analyst price targets ranging from $5.61 to $12 per share and an "Excellent" financial health score of 4.13 according to InvestingPro, investors seeking deeper insights into Medicus’s potential can access additional analysis and 6 key ProTips through the platform. The treatment, referred to as D-MNA, was well-tolerated at both tested doses, with no reported dose-limiting toxicities or serious adverse events.
The phase 2 study is designed as a randomized, double-blind, placebo-controlled trial, evaluating the efficacy of two dose levels of D-MNA against a placebo. It follows a phase 1 safety and tolerability study completed in March 2021, which also reported positive outcomes.
Alongside its clinical trials in the U.S. and plans for Europe, Medicus Pharma has submitted a clinical design to the Department of Health in Abu Dhabi and is exploring collaborations in the Asia-Pacific region.
This expansion of the clinical trial underscores Medicus Pharma’s commitment to advancing the treatment of BCC and reflects the company’s broader strategy to fast-track the development of disruptive therapeutic assets. The company is scheduled to report its next earnings on May 30, 2025, which could provide further insights into its development progress and financial position. The information for this article is based on a press release statement from Medicus Pharma Ltd.
In other recent news, Medicus Pharma Ltd. announced a Standby Equity Purchase Agreement with YA II PN, LTD, allowing the company to sell up to $15 million in common shares over 36 months. This agreement is contingent on a registration statement with the SEC. Additionally, Medicus Pharma has decided to delist from the TSX Venture Exchange due to low trading volume, focusing instead on Nasdaq where most of its trading occurs. The delisting is pending approval from the TSXV. In other developments, Medicus Pharma has submitted a clinical trial design to the UAE Department of Health for a non-invasive treatment of basal cell carcinoma, involving 36 patients across four sites. This trial is part of the company’s broader strategy to advance its global clinical development. Furthermore, Medicus Pharma has scheduled its annual and special meeting of shareholders for May 22, 2025, with a record date set for April 22, 2025. Lastly, the company recently canceled a previously scheduled shareholder meeting, with no further details provided on the reasons or any rescheduled dates.
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