1. Medicus expects to release SKNJCT-003 results by Q1 2026. 2. Phase 2 study of D-MNA completed enrollment of 90 patients. 3. Positive interim analysis showed over 60% clinical clearance in early testing. 4. FDA feedback suggests possible 505(b)(2) regulatory pathway for SkinJect. 5. A collaboration with Gorlin Syndrome Alliance aims to expand treatment access.
FAQ
Why Bullish?
MDCX's positive trial results and FDA collaboration may enhance investor confidence and stock price.
How important is it?
Upcoming trial results and FDA interactions are pivotal for investor sentiment and stock performance.
Why Long Term?
The planned trial outcomes and regulatory approvals could significantly shape the company's future revenue potential and market position.
Medicus Pharma Ltd. Completes Patient Enrollment for Phase 2 Clinical Study of D-MNA
Medicus Pharma Ltd. (NASDAQ: MDCX), a biotech company specializing in innovative therapeutics, has announced the successful enrollment of ninety (90) patients for its Phase 2 clinical trial, SKNJCT-003. This study aims to assess the safety and efficacy of the Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of nodular basal cell carcinoma (BCC) of the skin. The trial is currently being conducted across nine clinical sites in the United States.
Upcoming Milestones for SKNJCT-003
The company anticipates releasing topline results from the SKNJCT-003 trial by the end of the first quarter of 2026. Additionally, Medicus plans to request an end-of-Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA) during the first half of 2026. Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, remarked, “Successfully completing the U.S. enrollment of 90 patients for SKNJCT-003 brings us one step closer to offering a non-invasive, patient-friendly, cost-effective therapy for basal cell carcinoma, a market that we believe holds approximately $2 billion in potential.”
Design of the SKNJCT-003 Clinical Trial
The SKNJCT-003 study is structured as a randomized, double-blind, placebo-controlled trial with a multi-center design. It will involve a total of ninety subjects diagnosed with BCC. Participants are randomly assigned in a 1:1:1 ratio to one of 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 200μg D-MNA represents the maximum dosage evaluated during the Phase 1 safety study (SKNJCT-001), which successfully met its objectives regarding safety and tolerability.
Clinical Outcomes and Insights
The initial findings from the Phase 1 trial revealed that D-MNA was well tolerated among the 13 participants, with no serious adverse events or dose-limiting toxicities reported. Notably, 6 out of 6 participants demonstrated complete responses, characterized by the complete disappearance of BCC during follow-up examinations.
In March 2025, Medicus shared positive interim analysis results from the trial, highlighting a greater than 60% clinical clearance rate among patients enrolled at that time.
Regulatory Engagement and Future Developments
In September 2025, Medicus received favorable feedback from the FDA contextually supporting the SKNJCT development. This interaction confirmed the potential FDA approval pathway under the 505(b)(2) regulation for the non-invasive treatment of BCC using D-MNA. Furthermore, the company commenced its Phase 2 clinical study, SKNJCT-004, in the United Arab Emirates in October 2025.
In addition, following successful regulatory approvals in the United Kingdom, Medicus is ready to expand its ongoing trials for the D-MNA treatment.
Strategic Collaborations and Pipeline Expansions
Medicus has entered into a memorandum of understanding with Helix Nanotechnologies, Inc., to explore co-development opportunities in the area of infectious disease vaccines. Moreover, the company expanded its pipeline by acquiring Antev Limited, a UK-based biotech firm, which is developing Teverelix, a novel GnRH antagonist for prostate cancer treatment.
Patient Advocacy Initiatives
In October 2025, Medicus announced a collaboration with the Gorlin Syndrome Alliance (GSA) to facilitate compassionate access to their investigational product, SkinJect™, for patients suffering from Gorlin Syndrome. This collaboration aims to pursue expanded access protocols through the FDA while ensuring the integration of patient-led insights into the treatment development process.
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a precision-guided biotech and life sciences company dedicated to advancing innovative therapeutics to address significant medical needs.