Medicus Pharma Provides Interpretation of Positive Phase 2 SkinJect™ Dataset
Rhea-AI Summary
Medicus Pharma (NASDAQ: MDCX) reported Phase 2 SKNJCT-003 topline results for SkinJect: the 200-µg cohort achieved 73% clinical clearance and 40% histological clearance at Day 57, versus 38% clinical clearance in the P-MNA arm. The company calls the dataset decision-grade and plans an End-of-Phase-2 meeting with the FDA and to pursue partnering discussions.
Medicus also noted UK regulatory approvals to expand SKNJCT-003, completed U.S. enrollment of 90 patients, and recent corporate development activities including an August 2025 MoU and acquisitions.
Positive
- 73% clinical clearance in 200-µg cohort at Day 57
- 40% histological clearance in 200-µg cohort at Day 57
- Clear separation vs P-MNA: 73% vs 38% clinical clearance
- Completed enrollment of 90 U.S. patients for SKNJCT-003
- MHRA, HRA and WREC approvals granted to expand Phase 2 in UK
- FDA "study may proceed" clearance for Teverelix Phase 2b (Feb 2026)
Negative
- Active placebo (P-MNA) showed 38% clinical clearance, reducing net treatment margin
- Key collaborations and MoUs are non-binding and do not guarantee definitive agreements
News Market Reaction – MDCX
In the Mar 9 session, MDCX gained 34.26%, reflecting a significant positive market reaction. Argus tracked a peak move of +99.7% during that session. Our momentum scanner triggered 78 alerts that day, indicating high trading interest and price volatility. Trading volume was exceptionally heavy at 16.0x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 05 | Phase 2 topline data | Positive | -50.9% | Reported 73% clinical and 40% histological clearance at Day 57 for 200µg cohort. |
| Jan 05 | Conference presentation | Positive | +0.0% | Biotech Showcase talk highlighting Phase 2 catalysts and partnering readiness for SkinJect. |
| Dec 15 | Enrollment completed | Positive | -3.2% | Completed enrollment of 90 patients in SKNJCT-003 with prior interim >60% clinical clearance. |
| Nov 13 | UK approvals | Positive | -5.4% | Received full UK regulatory and ethical approvals to expand SKNJCT-003 Phase 2 study. |
| Oct 22 | UAE trial start | Positive | +0.0% | First patient treated in UAE SKNJCT-004 Phase 2 trial for non-invasive BCC treatment. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial headlines for SkinJect have generally been positive, yet the stock has often sold off or remained flat, suggesting a recurring divergence between upbeat trial progress and share price reactions.
Over the past several months, Medicus has advanced SkinJect through Phase 2, with UK regulatory approvals on Nov 13, 2025, UAE Phase 2 initiation on Oct 22, 2025, and completion of enrolment of 90 patients by Dec 15, 2025. A showcase presentation on Jan 5, 2026 highlighted upcoming topline data, which arrived on Mar 5, 2026 showing 73% clinical and 40% histological clearance at Day 57. Despite these clinically positive updates, price reactions around these clinical-trial milestones have tended to be negative or muted.
Key Terms
histological clearance medical
microneedle medical
basal cell carcinoma medical
End-of-Phase-2 meeting regulatory
Expanded Access IND Program regulatory
GnRH antagonist medical
Phase 2b medical
Investigational Medicinal Product Dossier regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
The Company Reported
PHILADELPHIA, March 09, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect® microneedle delivery of D-MNA and P-MNA for basal cell carcinoma (BCC).
The dataset demonstrated
We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm (P-MNA), that was not tip-loaded with the chemotherapeutic agent.
Active placebo arms are not uncommon in device-drug combination trials and can be an acceptable regulatory data point.
The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (
The Company believes the dataset represents decision-grade evidence supporting advancement of the SkinJect program toward regulatory discussions and potential strategic partnerships.
Interpreting Clinical and Histological Endpoints
The SKNJCT-003 study evaluated two complementary efficacy endpoints:
• Clinical clearance — visual disappearance of the treated lesion
• Histological clearance — absence of tumor cells on excisional biopsy
The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving
Interpreting Biological Activity in the Placebo Active Arm (P-MNA) Cohort:
The biological activity observed in the P-MNA is consistent with mechanisms well recognized in intratumoral device therapies and microneedle-based delivery systems, and is consistent with what the company had observed in the SKNJCT-001 Phase 1 safety and tolerability study in March of 2021, and the positively trending interim analysis of SKNJCT-003 in March of 2023 which demonstrated more than sixty (60) percent of clinical clearance.
Microneedle insertion into tumor tissue produces localized micro-injury that can trigger and amplify several biological processes, including:
• mechanical disruption of tumor architecture
• activation of wound-healing pathways
• localized immune signaling
Basal cell carcinoma is known to be a highly immunogenic tumor, and these localized biological responses can contribute to tumor regression even in the absence of an active therapeutic agent.
These mechanisms have been described in dermatologic oncology literature and reflect the inherent biological activity of microneedle-based delivery platforms.
Microneedle-based tumor disruption is increasingly recognized as a biologically active delivery platform, and the therapeutic contribution of the active drug should be interpreted on top of this device-mediated biological effect.
Importantly, the study demonstrated clear separation between the P-MNA cohort and the 200-µg treatment cohort at Day 57, where the active treatment group achieved
The Company believes that the dataset should be interpreted in the context of both:
- Biologic activity from the microneedle delivery platform
- Additional drug-related therapeutic effect
Potential Clinical Impact
Basal cell carcinoma is the most common cancer worldwide, with millions of lesions treated each year.
The
In clinical practice, lesions that achieve visual clearance are often monitored through routine dermatologic follow-up, reserving surgical procedures for lesions that recur or persist.
If confirmed in future studies, this approach could provide dermatologists with a minimally invasive treatment option that may reduce the need for Mohs surgery, the current surgical standard for many basal cell carcinomas.
The treatment approach may be particularly relevant for patients with Gorlin Syndrome, a rare genetic condition in which individuals may develop dozens or hundreds of basal cell carcinomas throughout their lifetime. For these patients, repeated surgical procedures can be extremely burdensome, impractical and potentially disfiguring; a non-invasive treatment could be transformative.
Dataset Supports Next Development Milestones
Based on the available data, the Company considers the current dataset to be decision-grade and supportive of the next phase of development. The Company intends to use these results to advance regulatory discussions with the Food and Drug Administration (the “FDA”) and to accelerate partnering discussions, as further elaborated on below.
Advance regulatory discussions with the FDA
The Company plans to proceed toward an End-of-Phase-2 meeting with the FDA to determine the optimal registrational development pathway, where the clinical development strategy may include:
• continued evaluation of the 200-µg dose
• potential optimization of patch application duration
• evaluation of additional treatment sessions
• potential refinement of treatment intervals
Accelerate partnering discussions
The dataset also provides a foundation for ongoing discussions with potential strategic partners, particularly companies active in dermatology and oncology.
Management Commentary
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, commented:
“We believe the SKNJCT-003 dataset reinforces the premise of SkinJect as a potential new treatment modality for basal cell carcinoma. The separation observed in the 200-µg treatment cohort, combined with the known biological activity of microneedle-based delivery systems, provides a strong foundation for advancing the program toward regulatory discussions and potential strategic partnerships.
The
Strategic Focus on Phase 2 De-Risking and Partnering
Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.
The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.
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 accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.
SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (MoU) with Helix Nanotechnologies, Inc. (HelixNano), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next-generation gonadotrophin-releasing hormone (GnRH) antagonist, as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
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, also known as nevoid basal cell carcinoma syndrome.
Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.
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. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.
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. The Company expects to secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.
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. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.
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).
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is 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 Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company’s submission for approval in the FDA Commissioner's National Priority Voucher program, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectations regarding reported efficacy findings and whether there will be material changes to its reported SKNJCT-003 topline results and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. 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, 2024 (the "Annual Report"), 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.
