Medicus Pharma Reports Positive Clinical Results for D-MNA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
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- 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.
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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 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 Files Application for Orphan Drug Designation with U.S. FDA for Skinject® in Gorlin Syndrome
- Medicus Pharma Submission: Medicus Pharma has submitted an application to the U.S. FDA for the designation of a new orphan drug.
- Targeted Condition: The application is specifically for the drug "Skinject®" aimed at treating Orlin Syndrome.
See More
Medicus Pharma Presents Phase 1 Data on Teverelix at AACE 2026
- Clinical Data Presentation: Medicus Pharma will present Phase 1 clinical data on Teverelix at the 2026 American Association of Clinical Endocrinology Annual Meeting, aiming to provide new therapies for hormone-driven diseases, particularly in women's health applications.
- Key Findings: In two Phase I studies conducted in Germany with 48 healthy premenopausal women, Teverelix demonstrated effective estradiol suppression and pharmacokinetic characteristics supporting infrequent dosing strategies, while showing good tolerability.
- Strategic Development Plan: The company plans to collaborate with Omics Labs in the UAE to develop Teverelix for symptomatic endometriosis, utilizing a genomics-enabled clinical development strategy designed to optimize patient selection and therapeutic response.
- Market Opportunity: With no long-acting injectable GnRH antagonists currently approved for endometriosis, Teverelix is positioned to become the first long-acting injectable therapy in this area, addressing the urgent market need for new treatments.
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 Files Application for Orphan Drug Designation with U.S. FDA for Skinject® in Gorlin Syndrome
- Medicus Pharma Submission: Medicus Pharma has submitted an application to the U.S. FDA for the designation of a new orphan drug.
- Targeted Condition: The application is specifically for the drug "Skinject®" aimed at treating Orlin Syndrome.
See More
Medicus Pharma Presents Phase 1 Data on Teverelix at AACE 2026
- Clinical Data Presentation: Medicus Pharma will present Phase 1 clinical data on Teverelix at the 2026 American Association of Clinical Endocrinology Annual Meeting, aiming to provide new therapies for hormone-driven diseases, particularly in women's health applications.
- Key Findings: In two Phase I studies conducted in Germany with 48 healthy premenopausal women, Teverelix demonstrated effective estradiol suppression and pharmacokinetic characteristics supporting infrequent dosing strategies, while showing good tolerability.
- Strategic Development Plan: The company plans to collaborate with Omics Labs in the UAE to develop Teverelix for symptomatic endometriosis, utilizing a genomics-enabled clinical development strategy designed to optimize patient selection and therapeutic response.
- Market Opportunity: With no long-acting injectable GnRH antagonists currently approved for endometriosis, Teverelix is positioned to become the first long-acting injectable therapy in this area, addressing the urgent market need for new treatments.
See More
