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Medicus Pharma Reports KOL Validation of SkinJect Phase 2 Data of 80% Overall Response Rate
Globenewswire· 2026-03-30 11:30
Core Insights - Medicus Pharma Ltd. reported independent clinical validation of its Phase 2 SkinJect® dataset, indicating that a majority of lesions in non-melanoma skin cancer patients may avoid immediate surgery [1][2] Clinical Study Findings - The SKNJCT-003 study is a randomized, double-blind, three-arm Phase 2 trial evaluating microneedle-mediated delivery of doxorubicin in patients with nodular basal cell carcinoma (BCC) [3] - The study design allows for a clear separation between active drug and device-only control, demonstrating a clinically meaningful therapeutic effect [3] - The 200µg dose cohort at Day 57 showed the highest observed activity, with approximately 75% of treated lesions potentially achieving visual tumor clearance [4] Treatment Implications - The findings suggest that SkinJect® could serve as a non-surgical treatment alternative, allowing many patients to avoid immediate surgical intervention [4] - The overall response rate was approximately 80%, with 73% clinical clearance and 40% histological clearance observed [5] Market Opportunity - Medicus Pharma's key therapeutic asset, SkinJect™, targets non-melanoma skin diseases, particularly BCC and Gorlin Syndrome, representing an estimated market opportunity of around $2 billion [12] - The company is also developing Teverelix, a next-generation GnRH antagonist for advanced prostate cancer, with a market opportunity of approximately $6 billion [13] Collaborations and Strategic Initiatives - Medicus Pharma announced a strategic collaboration with the Gorlin Syndrome Alliance to provide access to SkinJect for patients with Gorlin Syndrome [15][16] - The company is exploring co-development opportunities with Helix Nanotechnologies for infectious disease vaccines using its microneedle array delivery platform [13][14] - An AI-driven clinical data analytics platform is being developed in collaboration with Reliant AI Inc. to enhance clinical development efficiency [17]
Medicus Pharma advances SkinJect, Teverelix programs, eyes catalyst-rich 2026
Proactiveinvestors NA· 2026-03-26 12:39
Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]
Medicus Pharma Business Update Call to Highlight 80% Overall Response Rate (ORR) in Phase 2 SkinJect Study and Agentic AI-enabled Drug Development Plan
Globenewswire· 2026-03-26 11:30
Core Insights - Medicus Pharma Ltd. announced promising results from its Phase 2 SkinJect® study, indicating an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, suggesting that the majority of treated lesions may avoid surgery [2][9] - The company aims to address a significant unmet medical need in non-melanoma skin cancer, particularly basal cell carcinoma (BCC), which is the most common cancer worldwide [7][18] Group 1: Clinical Data and Analysis - The 200µg cohort demonstrated a 73% clinical clearance rate at Day 57, indicating that approximately three out of four treated lesions may achieve visual resolution, potentially allowing many patients to defer or avoid immediate surgical intervention [8][11] - The study showed continued improvement in clearance rates from Day 29 to Day 57, supporting the notion of a durable treatment effect [12] - The dataset is considered decision-grade, supporting regulatory engagement and potential business partnerships [14] Group 2: Expert Insights and Perspectives - Dr. Babar Rao, a key opinion leader in dermatology, will provide an independent clinical interpretation of the dataset during the upcoming conference call, emphasizing the clinical significance of the findings in the context of the broader BCC treatment landscape [4][5] - The findings highlight a significant treatment backlog in BCC, where patients may face delays or undergo unnecessary procedures [5] Group 3: Strategic Positioning and Future Plans - The company is entering a catalyst-rich period, with plans to refine histological clearance endpoints and engage in discussions with the FDA regarding the registrational study design [14] - Medicus is also focusing on optimizing clinical trial design and exploring co-development opportunities, including a collaboration with Helix Nanotechnologies for mRNA vaccine development [19][20] - The company aims to position SkinJect as a minimally invasive alternative to surgery, addressing a large and underserved BCC patient population [14][18]
Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate Update
Accessnewswire· 2026-03-25 20:30
Core Insights - Medicus Pharma Ltd. reported significant advancements in its clinical pipeline across dermatology, urology, and oncology, alongside strengthening its capital base to support Phase 2 programs [1] Financial Results - The company provided audited financial results for the year ended December 31, 2025, indicating a focus on financial health and operational progress [1] Development Programs - Medicus highlighted notable progress in its SkinJect® and Teverelix development programs, showcasing its commitment to innovative therapeutic solutions [1] - The company is expanding into precision medicine and AI-enabled clinical development, indicating a strategic shift towards integrating advanced technologies in its research [1]
Medicus Pharma Announces SkinJect® Phase 2 Principal Investigator and Key Opinion Leader (KOL), Babar K. Rao MD, FAAD, to Provide Clinical Interpretation of Positive Data During Business Update Webcast on March 26
Globenewswire· 2026-03-16 11:30
Core Insights - Medicus Pharma Ltd. announced a 73% clinical clearance rate in the 200-µg treatment cohort of the SKNJCT-003 Phase 2 clinical study, indicating that approximately three out of four treated lesions may allow patients to avoid immediate surgical intervention [1][4][10] Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on advancing clinical development programs for novel therapeutics, particularly in the field of oncology [17] - The company is actively engaged in multiple countries across three continents and has key therapeutic assets including SkinJect™ and Teverelix, representing significant market opportunities of approximately $2 billion and $6 billion, respectively [17][18] Clinical Study Details - The SKNJCT-003 study is a randomized, double-blind Phase 2 clinical trial evaluating the therapeutic contribution of doxorubicin delivered through the SkinJect microneedle platform in patients with nodular basal cell carcinoma [2][7] - The study results showed a clear separation in clinical response between the D-MNA treatment arm (73% clearance) and the P-MNA treatment arm (38% clearance) at Day 57, supporting the development of SkinJect as a non-surgical treatment option [8][11] Leadership and Expertise - Dr. Babar K. Rao, a recognized academic dermatologist and Principal Investigator of the SKNJCT-003 study, will join the company's leadership team [1][5] - Dr. Rao has extensive experience in dermatologic oncology and has authored over 200 peer-reviewed publications [6][7] Upcoming Events - A business update webcast is scheduled for March 26, 2026, where Dr. Rao will provide clinical interpretation of the SKNJCT-003 dataset [1][3][12] - The update will follow the filing of the Company's Form 10-K for fiscal year 2025, expected after market close on March 25, 2026 [2] Strategic Collaborations - The company is exploring collaborations, including a non-binding memorandum of understanding with Helix Nanotechnologies for the development of mRNA-based vaccines [18][22] - A strategic collaboration with the Gorlin Syndrome Alliance aims to provide access to SkinJect for patients suffering from Gorlin Syndrome [20][21]
Medicus Pharma Ltd. To Participate In The Longwood Miami CEO Forum
Accessnewswire· 2026-03-10 11:30
Core Insights - Medicus Pharma Ltd. will participate in the Longwood Miami CEO Forum, focusing on its AI-enabled drug development strategy aimed at enhancing clinical trial efficiency [1][2] - The company is actively engaged in developing innovative therapeutics, including a non-invasive treatment for basal cell skin cancer and a next-generation GnRH antagonist for prostate cancer [1][2] Company Participation and Events - Dr. Raza Bokhari, Executive Chairman & CEO, will be part of a panel titled "Accelerating the Path to Patient Care" at the Longwood Miami CEO Forum on March 12-13, 2026 [1] - The event will feature notable industry leaders and aims to foster discussions on healthcare innovation [1] Strategic Collaborations and Developments - Medicus has entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore joint development opportunities in mRNA technology [1][2] - The company completed the acquisition of Antev, focusing on a new treatment for advanced prostate cancer, which may improve patient compliance and outcomes [1][2] Clinical Trials and Regulatory Approvals - The company has received regulatory approvals in the UK for its Phase 2 clinical study evaluating D-MNA for treating basal cell carcinoma [2] - Medicus has successfully enrolled 90 patients in the U.S. for the same study and anticipates an end-of-Phase 2 meeting with the FDA in the first half of 2026 [2] Future Plans and Innovations - Medicus plans to collaborate with Reliant AI Inc. to develop an AI-driven clinical data analytics platform to enhance clinical trial efficiency [2] - The company has received FDA clearance to initiate a Phase 2b dose-optimization study of Teverelix for advanced prostate cancer [2]
Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort
Globenewswire· 2026-03-05 12:30
Core Insights - Medicus Pharma Ltd. has announced positive topline results from its Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin, with plans to finalize the Clinical Study Report (CSR) by Q2 2026 to support an end of Phase 2 meeting with the FDA [1][2][7] Clinical Study Overview - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular type BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] Topline Results - At Day 29 post-treatment, the clinical clearance rates were 33% for placebo, 47% for the 100µg D-MNA group, and 40% for the 200µg D-MNA group; histological clearance rates were 20%, 24%, and 27% respectively [4] - At Day 57, the 200µg cohort showed the highest activity with 73% clinical clearance and 40% histological clearance [4][6] Management Commentary - The CEO of Medicus expressed encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and strengthens the company's position in potential partnerships [6][7] Regulatory and Strategic Focus - The final CSR, including full safety analyses, is expected to be completed by Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The company aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [9]
Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort
Globenewswire· 2026-03-05 12:30
Core Insights - Medicus Pharma Ltd. announced positive topline results from its Phase 2 clinical study (SKNJCT-003) for Doxorubicin Microneedle Array (D-MNA) aimed at treating basal cell carcinoma (BCC) of the skin, indicating potential for FDA engagement and partnership readiness [1][2] Clinical Study Design and Results - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] - Topline results showed that at Day 29, the clinical clearance rates were 33% for placebo, 47% for 100µg D-MNA, and 40% for 200µg D-MNA; at Day 57, the rates improved to 38% for placebo, 42% for 100µg D-MNA, and 73% for 200µg D-MNA, with histological clearance rates of 20%, 24%, and 27% respectively at Day 29, and 38%, 33%, and 40% at Day 57 [4] Management Commentary - The CEO of Medicus expressed strong encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and enhances the company's position in potential partnership discussions [6] Regulatory and Strategic Focus - The final Clinical Study Report (CSR) is expected to be completed in Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The study was not powered for registrational endpoints, and no conclusions regarding regulatory approval can be drawn at this time [8] - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue strategic partnerships for late-stage development and commercialization [9]
Medicus Pharma To Participate in the 38th Annual Roth Conference
Globenewswire· 2026-03-03 12:30
Core Insights - Medicus Pharma Ltd. is participating in the 38th Annual Roth Conference, focusing on its clinical development programs and AI-enabled drug development strategy [1][2] Group 1: Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on advancing novel therapeutics assets [7] - The company is actively engaged in multiple countries across three continents [7] Group 2: Key Programs - SkinJect™ is a novel localized immuno-oncology product targeting non-melanoma skin diseases, particularly Gorlin Syndrome, representing a market opportunity of approximately $2 billion [3] - Teverelix is a next-generation GnRH antagonist for high-risk advanced prostate cancer patients, with a market opportunity of around $6 billion [4] Group 3: Development Strategy - The company aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development [5] - Medicus is assembling decision-grade clinical and regulatory data packages to support its partnering-focused model [5] Group 4: Recent Developments - In December 2025, the company completed enrollment of 90 patients for the Phase 2 clinical study (SKNJCT-003) evaluating D-MNA for treating BCC [15] - The company received "study may proceed" clearance from the FDA for its Phase 2b dose-optimization study of Teverelix in February 2026 [17]
Medicus Pharma's Teverelix Phase 2b trial cleared by FDA - ICYMI
Proactiveinvestors NA· 2026-02-14 16:50
Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the team includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain quality and best practices in content production [5]