Medicus Pharma Publishes Abridged Final Phase 2 SkinJect® Clinical Study Report (CSR) Results Identifying 200 µg D-MNA Patch as the Lead Development Dose
Final Phase 2 SkinJect CSR defines a 200 µg lead dose and supports Medicus Pharma’s FDA-authorized Gorlin syndrome Phase 2b trial design.
Rhea-AI Summary
Medicus Pharma (MDCX) has posted an abridged final Clinical Study Report (CSR) for its completed Phase 2 SKNJCT-003 trial of SkinJect® in nodular basal cell carcinoma on ClinicalTrials.gov, identifying the 200 µg D-MNA patch as the proposed pivotal dose.
The randomized, double-blind, multicenter study enrolled 90 patients at ten U.S. sites, with all patients completing treatment and follow-up, providing a full dataset for efficacy and safety analyses. The CSR underpins a refined development plan that adopts a composite complete-response endpoint (clinical plus histological clearance), later primary efficacy assessment timing, and a non-penetrating sham comparator for future registrational work. Medicus is prioritizing the FDA-authorized NDA‑enabling Phase 2b SKNJCT‑005 study in Gorlin syndrome patients with multiple BCC lesions and seeks partners for nodular BCC. The FDA has issued a “Study May Proceed” letter for SKNJCT‑005, which is expected to enroll up to approximately 50 patients.
Positive
- 90 patients enrolled and completed Phase 2 SKNJCT-003, yielding a full efficacy and safety dataset
- CSR designates the 200 µg SkinJect® patch as the proposed pivotal development dose
- Future registrational design targets about 90% power to detect a clinically meaningful treatment difference
- FDA issued a “Study May Proceed” letter for Phase 2b SKNJCT-005 in Gorlin syndrome
- Independent 2026 assessment modeled net price of about $25,800 per treatment
- Same assessment estimated U.S. SkinJect® Gorlin TAM at about $1.1 billion and potential peak U.S. revenue of about $383 million
Negative
- Orphan Drug and Rare Pediatric Disease designations are only pending, with no assurance of FDA approval
- Pricing, TAM and peak revenue figures are non-risk-adjusted and depend on successful approval and adoption
- Company notes no guarantee the Phase 2 dataset will be accepted for congress presentation or journal publication
News Explained
The update adds a roughly 90%-powered, potential single-pivotal-study design and conditional commercial estimates to an authorized-to-initiate program.
The newly disclosed design for FDA-authorized SKNJCT-005 is intended to provide approximately
The company also cites non-risk-adjusted estimates of approximately
Details
Market Reaction – MDCX
Following this news, MDCX has gained 1.71%, reflecting a mild positive market reaction. Argus tracked a peak move of +6.5% during the session. Our momentum scanner has triggered 15 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $0.17. Trading volume is exceptionally heavy at 227.7x the average, suggesting very strong buying interest.
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Key Figures
- Enrolled Patients
- 90 patients
- Completed Phase 2 SKNJCT-003 study
- Investigative Sites
- 10 U.S. sites
- Phase 2 SKNJCT-003 study
- Study Completion
- 90 patients
- All enrolled patients completed without discontinuations or withdrawals
- Proposed Pivotal Dose
- 200 µg
- SkinJect patch dose selected from Phase 2 findings
- Statistical Power
- Approximately 90%
- Planned registrational study design
- Planned Enrollment
- Up to approximately 50 patients
- SKNJCT-005 Phase 2b study in Gorlin syndrome
Previous Clinical trial Reports
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Reported 200µg cohort results with 55% histologic complete response and 64% clinical clearance.
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Received FDA Study May Proceed authorization for NDA-enabling SKNJCT-005 in Gorlin Syndrome.
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Clarified strongest 200µg cohort activity and planned registrational strategy for SKNJCT-003.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
clinical study report medical
modified intent-to-treat medical
new drug application regulatory
orphan drug designation regulatory
rare pediatric disease regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
CSR provides a clinical foundation for the Company’s recently announced capital-efficient focus on FDA-authorized Gorlin Syndrome NDA-enabling development program while supporting partnership discussions to advance nodular Basal Cell Carcinoma
PHILADELPHIA, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today announced that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT06608238) has been posted on ClinicalTrials.gov, providing transparent public access to the efficacy, safety, drug-delivery and clinical findings from the completed Phase 2 study.
Publication of the abridged CSR represents an important scientific milestone for SkinJect® and provides a transparent public record of the completed Phase 2 findings. The Company believes the dataset provides the clinical foundation for its focused development strategy, prioritizing the FDA-authorized SKNJCT-005 program in Gorlin syndrome patients with multiple basal cell carcinoma lesions, while pursuing strategic partnership opportunities to advance SkinJect® in nodular basal cell carcinoma (BCC).
The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites and evaluated two dose levels of SkinJect® compared with a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or study withdrawals, providing a complete clinical dataset for efficacy and safety evaluation.
The completed SKNJCT-003 CSR represents the definitive analysis of the Phase 2 program and incorporates the full clinical, pathological, and translational dataset generated during SKNJCT-003. Final efficacy analyses were conducted in the modified intent-to-treat population representing patients with centrally confirmed nodular basal cell carcinoma, providing what the Company believes to be the most clinically relevant assessment of SkinJect®’s therapeutic performance in its intended target population.
Dr. Faisal Mehmud, Chief Medical Officer of Medicus, commented:
“Publication of the SKNJCT-003 abridged Clinical Study Report is an important milestone in the development of SkinJect®. We believe that the completed Phase 2 study has provided the clinical information needed to define the next stage of development, including selection of the 200-mcg dose, continued improvement in clinical and histological clearance with longer follow-up, a favorable safety profile and important learnings around study design and assessment timing. These findings directly informed our FDA-authorized SKNJCT-005 program in Gorlin syndrome and provide a defined development package that we believe can support discussions with potential strategic partners interested in advancing SkinJect® in nodular basal cell carcinoma.”
Phase 2 Results Support a Focused, Capital-Efficient Development Strategy
Beyond reporting the efficacy and safety findings from SKNJCT-003, the completed Phase 2 program has defined key scientific elements relevant to future SkinJect® development, including dose selection, efficacy endpoints, assessment timing, comparator selection and statistical design. Medicus is applying these learnings to its FDA-authorized new drug application (NDA)-enabling development program in Gorlin syndrome patients and believes the same body of evidence can support a potential strategic partner in advancing a registrational program in nodular basal cell carcinoma.
The scientific conclusions documented in the CSR include:
- Selection of the 200 µg SkinJect® patch as the proposed pivotal dose.
- Adoption of a composite complete response endpoint incorporating both clinical and histological clearance.
- Selection of a later primary efficacy assessment, reflecting continued improvement in treatment response observed with longer follow-up.
- Replacement of the biologically active device-only comparator with a non-penetrating sham comparator designed to better isolate the pharmacologic contribution of SkinJect®.
- A randomized, double-blinded, sham-controlled registrational study intended to generate a robust, decision-grade clinical dataset.
- A statistical design providing approximately
90% power to detect a clinically meaningful treatment difference while supporting discussions with FDA regarding a potential single pivotal study approach.
Collectively, these findings provide a scientific bridge from the completed SKNJCT-003 study to the Company’s current SkinJect® strategy, where the Company believes the platform has the potential for greater clinical differentiation, a more focused regulatory pathway and attractive rare-disease commercial economics in treating Gorlin syndrome patients with multiple BCC lesions, while preserving the broader opportunity in nodular BCC through potential strategic partnering.
Medicus intends to continue clinical development through SKNJCT-005, in Gorlin syndrome, a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion directed procedures. Approximately 11,000 patients with Gorlin syndrome in the United States are estimated to have active BCC, representing approximately 50,000 Gorlin-associated BCC procedures annually. The U.S. Food and Drug Administration has issued a “Study May Proceed” letter authorizing initiation of the Company’s NDA-enabling registrational Phase 2b clinical study, SKNJCT-005, evaluating SkinJect® 200 µg skin patch in patients with Gorlin syndrome presenting with multiple BCCs. The study is designed to enroll up to approximately 50 patients.
The Company believes concentrating SkinJect® development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market. Medicus has submitted applications to the FDA for Orphan Drug Designation (“ODD”) and Rare Pediatric Disease (“RPD”) designation. If granted and applicable statutory requirements are ultimately satisfied, these designations could provide important regulatory and economic benefits, including potential orphan-drug incentives and potential eligibility for a Rare Pediatric Disease Priority Review Voucher (“RPD PRV”).
The Gorlin-focused strategy may also potentially support a differentiated reimbursement profile. A Company-commissioned 2026 independent commercial assessment incorporating interviews with physicians and payers modeled rare-disease-anchored net pricing of approximately
Scientific Dissemination
Publication of the abridged Clinical Study Report and public availability of the SKNJCT-003 results represent the first step in the Company’s broader scientific dissemination strategy. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a leading peer-reviewed medical journal, further supporting independent review of the study findings and continued engagement with the global dermatology and oncology communities; however, there is no guarantee that such dataset will be accepted for presentation or for publication.
For further information contact:
Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision-guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.
The Company’s current therapeutic assets are:
CD228V ADC, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, directed against melanotransferrin (CD228), a cell-surface protein expressed across multiple solid tumor types, such as melanoma, squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal cancer.
SkinJect®, an investigational novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) lesions in Gorlin Syndrome patients, a rare autosomal dominant disease also called nevoid BCC syndrome.
Teverelix®, an investigational next-generation GnRH antagonist, is being developed as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients, patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate and symptomatic endometriosis.
Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes “forward-looking statements” or “forward-looking information” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws (collectively, “forward-looking statements”). “Forward-looking statements” are defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, the posting of the abridged SKNJCT-003 CSR and the Company’s interpretation and characterization of the data contained therein, the selection of the 200-mcg dose as the proposed pivotal dose, the Company’s strategy to prioritize continued clinical development of SkinJect® in Gorlin syndrome, the initiation, conduct and results of SKNJCT-005, the Company’s efforts to identify and enter into strategic collaborations, licensing arrangements or other partnerships for development of SkinJect® in nodular basal cell carcinoma, the design, timing, conduct and results of any future partner-led nodular basal cell carcinoma study and whether the resulting data will be sufficient to support a future New Drug Application for SkinJect®, whether the FDA will grant Orphan Drug Designation or Rare Pediatric Disease designation for SkinJect® in Gorlin Syndrome and the benefits of any such designation, if granted, the potential pricing of, and reimbursement for, SkinJect®, if approved, and the estimates of net price per treatment, total addressable market and potential peak U.S. revenue described in this news release, Antev’s future, the development of Teverelix® and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women’s health indications like endometriosis, the Company’s co-development with Pfizer with respect to CD228V and the anticipated benefits thereof, the Company’s plans and expectations relating to the development, manufacture and commercialization of CD228V across human therapeutic indications, including the Company’s intention to focus initial development on melanoma with potential subsequent development in squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and esophageal cancer, the timing, design, conduct and results of any future clinical study of CD228V, and the potential market opportunities related to CD228V, SkinJect® and Teverelix® and the Company’s other therapeutic assets. Forward-looking statements are often, but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", “could,” “designed,” "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2025, and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
FAQ
What is the SKNJCT-003 Phase 2 trial design and who was studied?
SKNJCT-003 was a randomized, double-blind, multicenter Phase 2 study conducted at ten U.S. investigative sites. It evaluated two dose levels of SkinJect® against a device-only microneedle comparator in patients with centrally confirmed nodular basal cell carcinoma. All 90 enrolled patients completed the study without treatment discontinuations or withdrawals, enabling modified intent-to-treat efficacy analyses in this target population.
How will the Phase 2 CSR influence future SkinJect® trials?
The CSR supports selection of the 200 µg patch as the proposed pivotal dose, use of a composite complete response endpoint combining clinical and histological clearance, a later primary efficacy assessment to capture continued response improvement, replacement of the active device-only comparator with a non-penetrating sham comparator, and a randomized, double-blinded, sham-controlled registrational design with approximately 90% statistical power.
What is Medicus Pharma’s development focus for SkinJect® after this CSR?
Medicus is concentrating SkinJect® development on Gorlin syndrome, a rare autosomal dominant disease in which patients may develop numerous basal cell carcinoma lesions and undergo repeated procedures. The company is advancing the FDA-authorized NDA-enabling Phase 2b SKNJCT-005 study in Gorlin patients with multiple BCCs and is pursuing potential strategic partnerships to run a registrational program in nodular basal cell carcinoma.
What is known about the Gorlin syndrome market opportunity for SkinJect®?
A company-commissioned independent commercial assessment in 2026, using physician and payer interviews, modeled rare-disease-anchored U.S. net pricing of approximately $25,800 per treatment, an implied total addressable market of about $1.1 billion, and potential peak U.S. revenue of roughly $383 million for SkinJect® in Gorlin syndrome. These estimates are non-risk-adjusted and depend on successful clinical development, regulatory approval, reimbursement and adoption.
What regulatory designations has Medicus sought for SkinJect® in Gorlin syndrome?
Medicus has submitted applications to the FDA for Orphan Drug Designation and Rare Pediatric Disease designation for SkinJect® in Gorlin syndrome. If either is granted and statutory requirements are met, the company states that potential benefits could include orphan-drug incentives and possible eligibility for a Rare Pediatric Disease Priority Review Voucher, but there is no assurance such designations will be granted.
How is Medicus planning to disseminate the Phase 2 SkinJect® data?
The abridged SKNJCT-003 CSR has been posted on ClinicalTrials.gov as the first step in broader dissemination. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a leading peer-reviewed medical journal, while cautioning there is no guarantee of acceptance.