Medicus Pharma SKNJCT-003 Study Shows Positive Dose Response
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 06 2026
0mins
Medicus Pharma announced results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of doxorubicin microneedle Array to treat nodular basal cell carcinoma of the skin. The expanded central pathology-verified efficacy analysis of 69 participants showed a progressive, dose-dependent improvement, with the 200microgram cohort achieving the highest clinical and histological clearance rates by day 57 vs. device-only control. The company said the dataset, which also confirmed a favorable safety and tolerability profile without drug-related serious adverse events or systemic doxorubicin toxicity, supports a registrational path and planned end-of-Phase 2 discussions with the FDA. "We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program," said Raza Bokhari, chairman and CEO of Medicus.
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About MDCX
Medicus Pharma Ltd. is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets. SkinJect Inc., a wholly owned subsidiary of the Company, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. It is conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. It has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the UAE. Its subsidiary, Antev Limited, is a late clinical stage biotech company, developing Teverelix, a GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse episodes due to enlarged prostate.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Medicus Pharma Reports Q1 Financial Results
- Earnings Per Share Loss: Medicus Pharma reported a Q1 GAAP EPS of -$0.31, indicating ongoing challenges in profitability that may affect investor confidence moving forward.
- Cash Position Improvement: As of March 31, 2026, cash and cash equivalents stood at $6.4 million, up from $4.0 million in the same period of 2025, suggesting improved liquidity management within the company.
- Rising Operating Expenses: Operating expenses for Q1 reached $8.6 million, significantly higher than $5.1 million in Q1 2025, primarily driven by increases in general and administrative costs as well as R&D spending, which may pressure future profitability.
- Widening Net Loss: The company reported a net loss of $9.0 million for Q1, compared to a loss of $5.1 million in Q1 2025, reflecting ongoing financial strain and an increasingly competitive market environment.
See More
Medicus Pharma Reports Q1 2026 Financial Results and Corporate Update
- Clinical Advancements: In Q1 2026, Medicus Pharma continued to advance its clinical development of SkinJect® and Teverelix®, with the Phase 2 SKNJCT-003 study showing positive dose-response and registrational-grade clearance rates in the 200-µg treatment cohort, which is expected to facilitate FDA engagement for potential registration pathways.
- Financial Position: The company secured approximately $10 million through market financing in Q1, with cash and cash equivalents reaching $6.4 million, despite rising operating expenses of $8.6 million and a net loss of $9 million, indicating ongoing financial pressure.
- Strategic Collaborations: Medicus continues its collaboration with the Gorlin Syndrome Alliance to provide compassionate access to SkinJect® for Gorlin syndrome patients, further expanding market opportunities and enhancing brand influence.
- Future Outlook: The company anticipates a catalyst-rich 2026, planning an FDA Phase 2 meeting to define registration pathways and evaluating collaboration opportunities with HelixNano, reflecting a positive outlook for future growth.
See More
Medicus Pharma Reports Positive Clinical Results for D-MNA
- Clinical Trial Results: Medicus Pharma's expanded analysis from the SKNJCT-003 study shows that the 200µg D-MNA cohort achieved a clinical clearance rate of 64% at Day 57 among 69 participants, significantly outperforming the device control group's 29%, indicating a progressive enhancement in D-MNA's efficacy for treating nodular basal cell carcinoma.
- Safety Analysis: The study reported no drug-related serious adverse events, and D-MNA demonstrated a favorable safety profile, supporting its repeatable use in clinical applications and bolstering confidence for future FDA registration.
- Dose-Response Relationship: The expanded analysis revealed a clear dose-response relationship for D-MNA, with the 200µg cohort showing sustained improvements across clinical and histological endpoints, suggesting its potential to shift the treatment paradigm for BCC.
- Future Development Path: The CEO of Medicus Pharma stated that these results provide a robust clinical and regulatory foundation for the SKNJCT-003 program, which is expected to facilitate discussions with the FDA for registration, accelerating SkinJect's market entry process.
See More
Medicus Pharma Advances SkinJect Development for Gorlin Syndrome
- Policy Advocacy Meetings: Medicus Pharma's CEO Dr. Raza Bokhari and the leadership team engaged with senior lawmakers on Capitol Hill to advocate for Orphan Drug Designation and IND approval for SkinJect®, demonstrating the company's proactive involvement and influence in healthcare policy.
- Rare Disease Treatment Need: Patients with Gorlin Syndrome face lifelong recurrence of basal cell carcinomas, with current treatments heavily reliant on surgery and lacking FDA-approved non-surgical options; the development of SkinJect® aims to address this significant market gap and meet urgent patient needs.
- Clinical Development Strategy: The company is advancing a registrational development pathway for SkinJect®, focusing on generating decision-grade data to expedite development in high-burden patient populations, indicating its commitment to innovative therapies and recognition of market potential.
- Strategic Partnerships: Collaboration with the Gorlin Syndrome Alliance aims to provide compassionate access to SkinJect® for patients, further enhancing Medicus's influence in the rare disease space and showcasing its dedication to patient welfare.
See More
Highlights from New to The Street Broadcast
- Rich Program Content: Tonight's episode #746 of New to The Street will air on Bloomberg Television, reaching millions of households across the U.S., MENA, and Latin America, showcasing innovations and developments from various companies.
- Industry Leaders Speak: Dr. Jonathan C. Javitt, CEO of NRx Pharmaceuticals, discusses the company's innovative pipeline in critical care and neuropsychiatric treatments, emphasizing its leading position in the healthcare sector.
- Digital Transformation: Performance Golf, a leading digital golf instruction platform, is transforming how players improve their game worldwide, demonstrating the potential of technology in traditional sports.
- Diverse Sponsorships: The program is further supported by commercial sponsorships from Medicus Pharma, IGC Pharma, Roadzen, and Lantern Pharma, enhancing its influence in the healthcare, AI, and technology sectors.
See More
Medicus Pharma Submits Orphan Drug Designation for SkinJect®
- Orphan Drug Application: Medicus Pharma has submitted an Orphan Drug Designation application to the U.S. FDA for SkinJect® (D-MNA) targeting basal cell carcinoma in patients with Gorlin Syndrome, marking a strategic expansion into a high unmet need orphan indication that is expected to enhance market competitiveness.
- High-Burden Rare Disease: Gorlin Syndrome affects approximately 11,000 patients in the U.S., with individuals potentially developing dozens to over 1,000 basal cell carcinomas throughout their lives; current treatments rely heavily on surgery, lacking FDA-approved therapies, making SkinJect® a promising solution to alleviate both physical and psychological burdens on patients.
- Localized Treatment Advantages: SkinJect® is a dissolvable microneedle array designed for direct delivery of doxorubicin into tumor tissue, featuring high local concentration and minimal systemic exposure, which is particularly beneficial for managing multiple lesions in Gorlin Syndrome patients, potentially improving their treatment experience significantly.
- Clinical Research Progress: SkinJect® has demonstrated a favorable safety profile and evidence of clinical clearance in Phase 1 and Phase 2 studies for basal cell carcinoma; if granted orphan drug status, it will provide Medicus with 7 years of market exclusivity, enhancing its differentiated clinical and regulatory pathway.
See More
Medicus Pharma Reports Q1 Financial Results
- Earnings Per Share Loss: Medicus Pharma reported a Q1 GAAP EPS of -$0.31, indicating ongoing challenges in profitability that may affect investor confidence moving forward.
- Cash Position Improvement: As of March 31, 2026, cash and cash equivalents stood at $6.4 million, up from $4.0 million in the same period of 2025, suggesting improved liquidity management within the company.
- Rising Operating Expenses: Operating expenses for Q1 reached $8.6 million, significantly higher than $5.1 million in Q1 2025, primarily driven by increases in general and administrative costs as well as R&D spending, which may pressure future profitability.
- Widening Net Loss: The company reported a net loss of $9.0 million for Q1, compared to a loss of $5.1 million in Q1 2025, reflecting ongoing financial strain and an increasingly competitive market environment.
See More
Medicus Pharma Reports Q1 2026 Financial Results and Corporate Update
- Clinical Advancements: In Q1 2026, Medicus Pharma continued to advance its clinical development of SkinJect® and Teverelix®, with the Phase 2 SKNJCT-003 study showing positive dose-response and registrational-grade clearance rates in the 200-µg treatment cohort, which is expected to facilitate FDA engagement for potential registration pathways.
- Financial Position: The company secured approximately $10 million through market financing in Q1, with cash and cash equivalents reaching $6.4 million, despite rising operating expenses of $8.6 million and a net loss of $9 million, indicating ongoing financial pressure.
- Strategic Collaborations: Medicus continues its collaboration with the Gorlin Syndrome Alliance to provide compassionate access to SkinJect® for Gorlin syndrome patients, further expanding market opportunities and enhancing brand influence.
- Future Outlook: The company anticipates a catalyst-rich 2026, planning an FDA Phase 2 meeting to define registration pathways and evaluating collaboration opportunities with HelixNano, reflecting a positive outlook for future growth.
See More
Medicus Pharma Reports Positive Clinical Results for D-MNA
- Clinical Trial Results: Medicus Pharma's expanded analysis from the SKNJCT-003 study shows that the 200µg D-MNA cohort achieved a clinical clearance rate of 64% at Day 57 among 69 participants, significantly outperforming the device control group's 29%, indicating a progressive enhancement in D-MNA's efficacy for treating nodular basal cell carcinoma.
- Safety Analysis: The study reported no drug-related serious adverse events, and D-MNA demonstrated a favorable safety profile, supporting its repeatable use in clinical applications and bolstering confidence for future FDA registration.
- Dose-Response Relationship: The expanded analysis revealed a clear dose-response relationship for D-MNA, with the 200µg cohort showing sustained improvements across clinical and histological endpoints, suggesting its potential to shift the treatment paradigm for BCC.
- Future Development Path: The CEO of Medicus Pharma stated that these results provide a robust clinical and regulatory foundation for the SKNJCT-003 program, which is expected to facilitate discussions with the FDA for registration, accelerating SkinJect's market entry process.
See More
Medicus Pharma Advances SkinJect Development for Gorlin Syndrome
- Policy Advocacy Meetings: Medicus Pharma's CEO Dr. Raza Bokhari and the leadership team engaged with senior lawmakers on Capitol Hill to advocate for Orphan Drug Designation and IND approval for SkinJect®, demonstrating the company's proactive involvement and influence in healthcare policy.
- Rare Disease Treatment Need: Patients with Gorlin Syndrome face lifelong recurrence of basal cell carcinomas, with current treatments heavily reliant on surgery and lacking FDA-approved non-surgical options; the development of SkinJect® aims to address this significant market gap and meet urgent patient needs.
- Clinical Development Strategy: The company is advancing a registrational development pathway for SkinJect®, focusing on generating decision-grade data to expedite development in high-burden patient populations, indicating its commitment to innovative therapies and recognition of market potential.
- Strategic Partnerships: Collaboration with the Gorlin Syndrome Alliance aims to provide compassionate access to SkinJect® for patients, further enhancing Medicus's influence in the rare disease space and showcasing its dedication to patient welfare.
See More
Highlights from New to The Street Broadcast
- Rich Program Content: Tonight's episode #746 of New to The Street will air on Bloomberg Television, reaching millions of households across the U.S., MENA, and Latin America, showcasing innovations and developments from various companies.
- Industry Leaders Speak: Dr. Jonathan C. Javitt, CEO of NRx Pharmaceuticals, discusses the company's innovative pipeline in critical care and neuropsychiatric treatments, emphasizing its leading position in the healthcare sector.
- Digital Transformation: Performance Golf, a leading digital golf instruction platform, is transforming how players improve their game worldwide, demonstrating the potential of technology in traditional sports.
- Diverse Sponsorships: The program is further supported by commercial sponsorships from Medicus Pharma, IGC Pharma, Roadzen, and Lantern Pharma, enhancing its influence in the healthcare, AI, and technology sectors.
See More
Medicus Pharma Submits Orphan Drug Designation for SkinJect®
- Orphan Drug Application: Medicus Pharma has submitted an Orphan Drug Designation application to the U.S. FDA for SkinJect® (D-MNA) targeting basal cell carcinoma in patients with Gorlin Syndrome, marking a strategic expansion into a high unmet need orphan indication that is expected to enhance market competitiveness.
- High-Burden Rare Disease: Gorlin Syndrome affects approximately 11,000 patients in the U.S., with individuals potentially developing dozens to over 1,000 basal cell carcinomas throughout their lives; current treatments rely heavily on surgery, lacking FDA-approved therapies, making SkinJect® a promising solution to alleviate both physical and psychological burdens on patients.
- Localized Treatment Advantages: SkinJect® is a dissolvable microneedle array designed for direct delivery of doxorubicin into tumor tissue, featuring high local concentration and minimal systemic exposure, which is particularly beneficial for managing multiple lesions in Gorlin Syndrome patients, potentially improving their treatment experience significantly.
- Clinical Research Progress: SkinJect® has demonstrated a favorable safety profile and evidence of clinical clearance in Phase 1 and Phase 2 studies for basal cell carcinoma; if granted orphan drug status, it will provide Medicus with 7 years of market exclusivity, enhancing its differentiated clinical and regulatory pathway.
See More
