PHILADELPHIA, March 5, 2026 — Leads & Copy —
Medicus Pharma Ltd. (NASDAQ: MDCX) announced positive topline results from its Phase 2 clinical study (SKNJCT-003), which evaluated the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin.
The company believes these results support an end-of-phase 2 (EOP2) meeting with the FDA in the first half of 2026 and will accelerate partnering readiness.
The SKNJCT-003 study was a randomized, double-blind, placebo-controlled, multi-center trial involving 90 patients with nodular BCC. It compared two dose levels of D-MNA to a placebo control group.
Participants were divided into three groups:
- Placebo-controlled group receiving P-MNA
- Low-dose group receiving 100μg of D-MNA
- High-dose group receiving 200μg of D-MNA
The primary endpoint was defined as achieving both clinical and histological clearance at a prespecified post-treatment timepoint. These timepoints were Day 29 for 47 patients and Day 57 for 43 patients.
Topline results showed increased clearance rates between Day 29 and Day 57. The 200µg cohort showed the highest activity at Day 57, achieving 73% Clinical Clearance and 40% Histological Clearance (CR).
Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, stated the results validate the company’s scientific and investment thesis and provide evidence of clinical activity, especially at the 200-microgram dose. He added that the increase in clearance rates at Day 57 reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. He also believes the data strengthens the company’s position in partnering discussions and may accelerate strategic engagement.
The Clinical Study Report (CSR), including full safety analyses, is expected to be completed in Q2 2026. The company does not anticipate material changes to the reported efficacy findings.
Medicus’ development strategy focuses on advancing programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships for late-stage development and commercialization.
Medicus Pharma Ltd. is a biotech/life sciences company focused on accelerating the clinical development programs of therapeutics assets. SkinJect Inc., a subsidiary, is focused on commercializing a non-invasive treatment for basal cell skin cancer.
In August 2025, Medicus announced a non-binding memorandum of understanding with Helix Nanotechnologies, Inc. In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix.
In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome. In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin.
In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform.
In February 2026, the Company announced that it has received “study may proceed” clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC).
Source: Medicus Pharma Ltd.
