Medicus Pharma gets FDA nod for 505(b)(2) pathway in skin cancer treatment

PHILADELPHIA - Medicus Pharma Ltd. (NASDAQ:MDCX) announced Monday it has received positive feedback from the U.S. Food and Drug Administration regarding its regulatory pathway for treating basal cell carcinoma (BCC) using dissolvable doxorubicin-containing microneedle arrays (D-MNA). According to InvestingPro data, the clinical-stage company maintains a strong cash position relative to debt, though it currently trades at $2.63 with analyst price targets ranging from $20 to $27.

The FDA indicated the company may pursue the 505(b)(2) regulatory pathway for its Skinject product, potentially allowing Medicus to leverage existing doxorubicin safety data rather than conducting a full development program.

The agency provided guidance on several aspects of the company’s clinical development plan, including appropriate primary endpoints, patient population definitions, and study design for future trials intended to demonstrate D-MNA effectiveness in treating BCC.

Medicus is currently conducting a Phase 2 clinical study (SKNJCT-003) across nine U.S. clinical sites, with patient recruitment expected to complete before the end of Q4 2025. The company plans to request an End-of-Phase 2 meeting with the FDA in Q1 2026.

In March, Medicus reported preliminary results from an interim analysis showing more than 60% clinical clearance in the SKNJCT-003 study. The company has expanded the trial to include 90 participants, with more than 75% already randomized.

A parallel clinical study (SKNJCT-004) is underway in the United Arab Emirates, expected to randomize 36 patients across six sites.

"Establishing 505(b)(2) as a regulatory pathway to bring to market our novel, non-invasive Skinject D-MNA treatment to cure BCC of the skin, is a game changer," said Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO, in the press release.

The company estimates the potential market opportunity for its BCC treatment at approximately $2 billion. With a current market capitalization of just $51 million and negative earnings of $1.37 per share, Medicus faces significant execution challenges ahead. InvestingPro analysis reveals 7 additional key insights about the company’s financial position and growth prospects, available to subscribers.

In other recent news, Medicus Pharma Ltd. has announced a definitive agreement to acquire UK-based Antev Ltd. in an all-stock transaction. Antev shareholders will receive approximately 2.67 million Medicus common shares, accounting for about 17% of Medicus’ outstanding shares, with potential contingent payments up to $65 million based on future FDA approvals. Additionally, Medicus has engaged Deloitte LLP as its exclusive financial adviser to explore potential out-licensing opportunities for its Doxorubicin Microneedle Array (D-MNA) treatment for Basal Cell Carcinoma. The company has also commenced patient recruitment for its SKNJCT-004 Phase 2 clinical study at Cleveland Clinic Abu Dhabi, focusing on a non-invasive treatment for basal cell carcinoma. Furthermore, the U.S. FDA has accepted Medicus’ Type C meeting request for its D-MNA skin cancer treatment program, with a response anticipated by the end of Q3 2025. The ongoing SKNJCT-003 Phase 2 study has randomized over 75% of the planned 90 participants. These developments underscore Medicus Pharma’s active engagement in advancing its skin cancer treatment initiatives.

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