Medicus Pharma Ltd. (Nasdaq: MDCX) has selected the 200 µg dose of SkinJect as its proposed pivotal dose after completing a Phase 2 study in patients with nodular basal cell carcinoma.
According to the company’s September 10 announcement, an abridged clinical study report for SKNJCT-003 has been posted on ClinicalTrials.gov. The randomized, double-blind study enrolled 90 patients across 10 U.S. sites and compared two SkinJect dose levels with a device-only microneedle comparator.
All 90 participants completed the trial without treatment discontinuations or withdrawals. Final efficacy analyses used a modified intent-to-treat population consisting of patients whose nodular basal cell carcinoma was confirmed centrally.
SkinJect is an investigational dissolvable microneedle-array patch designed to deliver doxorubicin directly into skin lesions. The localized approach is being developed as a potential alternative to repeated lesion-removal procedures in selected patients.
In its second-quarter SEC filing, Medicus cited previously reported results showing 55% histological clearance and 64% clinical clearance in patients treated with the 200 µg dose. However, the September 10 announcement did not provide a final arm-by-arm response table, p-values or the number of patients included in the modified intent-to-treat analysis.
The completed study also changed how Medicus plans to design future trials. The company intends to use a composite complete-response endpoint requiring both clinical and histological clearance, assess efficacy later in the treatment period and replace the penetrating device-only comparator with a nonpenetrating sham.
Chief Medical Officer Faisal Mehmud said the study “has provided the clinical information needed to define the next stage of development.”
Medicus is now prioritizing SKNJCT-005, a planned Phase 2b study of the 200 µg patch in up to approximately 50 patients with Gorlin syndrome and multiple basal cell carcinomas. The FDA has issued a “Study May Proceed” letter, but that authorization is not approval of SkinJect or confirmation that the trial will produce sufficient evidence for a marketing application.
The company has also submitted applications for Orphan Drug and Rare Pediatric Disease designations. Both requests remain pending. Separately, Medicus is seeking a strategic partner to advance SkinJect in the broader nodular basal cell carcinoma market.
Financial capacity remains a risk. Medicus reported US$15.2 million in cash and US$10 million in restricted cash as of June 30, 2026. It recorded a quarterly net loss of approximately US$11.7 million, and its SEC filing identified substantial doubt about its ability to continue as a going concern.
Upcoming Catalysts
- Initiation and enrollment of the SKNJCT-005 Gorlin syndrome study
- FDA decisions on the pending designation applications
- Presentation or publication of the complete Phase 2 dataset
- A potential SkinJect partnership for nodular basal cell carcinoma
- Future financing, cash-use and debt updates
Sources
- Medicus Pharma final Phase 2 SkinJect report — September 10, 2026
- SKNJCT-003 clinical-trial record — ClinicalTrials.gov
- Medicus Pharma Form 10-Q for the quarter ended June 30, 2026
- Independent coverage of the Phase 2 report — Dermatology Times
Editorial Disclosure
This article is based entirely on publicly available information including company announcements, SEC filings, the federal clinical-trial registry and publicly available news sources. Securities discussed or referenced include Medicus Pharma Ltd. (Nasdaq: MDCX). Biotech Stocks Daily has not received compensation from Medicus Pharma, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
Sources used include Medicus Pharma’s September 10, 2026 Phase 2 announcement, its Form 10-Q for the quarter ended June 30, 2026, ClinicalTrials.gov and coverage published by Dermatology Times. Information concerning SkinJect’s mechanism, development strategy and expected milestones originated primarily from Medicus and has not been independently validated by Biotech Stocks Daily.
SkinJect remains investigational and has not been approved by the FDA. The “Study May Proceed” letter permits the planned study to begin but does not represent product approval or establish safety or efficacy. The completed Phase 2 study involved 90 patients, and its findings may not be reproduced in a larger or differently designed trial. The latest announcement did not provide a complete arm-by-arm efficacy table, statistical comparisons or the size of the final modified intent-to-treat population.
The Orphan Drug and Rare Pediatric Disease designation applications remain pending. Medicus’s commercial estimates are company-commissioned, non-risk-adjusted projections dependent on successful development, regulatory approval, reimbursement and adoption. There is no assurance that the complete dataset will be accepted for presentation or publication, or that Medicus will secure a development partner.
Financial information is reported in U.S. dollars and reflects the company’s position as of June 30, 2026. Approximately US$10 million of the reported cash balance was restricted and unavailable for general corporate purposes except under the applicable financing arrangements. Medicus has recorded continuing losses, carries secured debt and identified substantial doubt about its ability to continue as a going concern. Additional financing may be required and could dilute existing shareholders.
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