Medicus Pharma advances skin cancer treatment as FDA meeting approaches

Published 21/08/2025, 12:46
Medicus Pharma advances skin cancer treatment as FDA meeting approaches

PHILADELPHIA - Medicus Pharma Ltd. (NASDAQ:MDCX), a small-cap biotech company currently valued at $34.92 million, announced Thursday that the U.S. Food and Drug Administration has accepted its Type C meeting request regarding its D-MNA skin cancer treatment program, with a response expected before the end of Q3 2025. The announcement comes as the company’s stock trades near its 52-week low of $1.80, having declined 49% over the past six months.

The company also reported that its SKNJCT-003 Phase 2 clinical study has now randomized more than 75% of the planned 90 participants. The study is evaluating a dissolvable microneedle patch to deliver chemotherapeutic agents for treating basal cell carcinoma (BCC).

The randomized, double-blind, placebo-controlled trial is comparing two dose levels of D-MNA against a placebo. In March 2025, an interim analysis showed more than 60% clinical clearance after half of the then-targeted 60 patients were randomized, according to the company’s press release.

Medicus is conducting the trial at nine clinical sites across the United States, with additional sites being established in Europe. A separate clinical study (SKNJCT-004) is also underway in the United Arab Emirates with 36 planned participants across four medical facilities.

The company’s cash position stood at $9.7 million at the end of Q2 2025, up from $4.0 million at the end of Q1, bolstered by $11.5 million in net proceeds from financing transactions and warrant exercises. Operating expenses increased to $6.0 million for the quarter compared to $3.6 million in the same period last year. According to InvestingPro analysis, the company’s overall financial health score is rated as WEAK, with analysts maintaining price targets ranging from $12 to $27, significantly above the current trading price of $2.04.

In June 2025, Medicus entered into a definitive agreement to acquire Antev Ltd., a UK-based company developing a GnRH antagonist for prostate cancer patients. The company also signed a non-binding memorandum of understanding with Helix Nanotechnologies Inc. in August regarding potential development of thermostable infectious disease mRNA vaccines. InvestingPro subscribers can access additional insights, including 6 key ProTips about Medicus’s valuation metrics and growth potential, helping investors make more informed decisions about this developing biotech story.

In other recent news, Medicus Pharma Ltd. has completed a public offering, raising $7 million through the sale of 2,260,000 units at $3.10 each. The funds are intended to advance clinical trials, particularly a Phase 2 trial for a basal cell carcinoma treatment. Additionally, Medicus Pharma announced a definitive agreement to acquire UK-based Antev Ltd. in an all-stock transaction, potentially worth up to $65 million, contingent on future regulatory approvals. The acquisition will result in Antev shareholders receiving approximately 17% of Medicus’ outstanding shares.

Furthermore, the company has appointed Deloitte LLP as its exclusive financial adviser to explore out-licensing opportunities for its Doxorubicin Microneedle Array (D-MNA) for basal cell carcinoma treatment. In another strategic move, Medicus Pharma has appointed Andrew Smith as Chief Operating Officer, bringing over three decades of experience to the role. The company is also advancing its D-MNA patch for equine squamous cell carcinoma, aiming for FDA concurrence under the Investigational New Animal Drug designation. The patch has already received a Minor Use in Major Species designation, potentially providing a seven-year exclusive marketing period post-approval.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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