MDCX

Company Advances SkinJect® and Teverelix® Clinical Programs While Strengthening Financing Flexibility and Expanding Strategic Development Initiatives PHILADELPHIA, May 14, 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 reported financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect® and Teverelix® development programs. During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives. The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect® Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort. In parallel, Medicus advanced Teverelix®, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention. Management Commentary: “During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect® data, advancement of Teverelix® into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives,” stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. “We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond.”...

200µg Cohort Achieves 55% Complete Response at Day 57 Emerging as Registrational Grade Lead Regimen PHILADELPHIA, May 06, 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 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 (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer. These additional pre-specified analysis, build upon the previously reported positive topline results, provide expanded biological, histologic, and safety insights that further strengthen SkinJect’s therapeutic profile and future registrational discussions with the U.S. Food and Drug Administration (FDA). These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies. SKNJCT-003 Study Design Overview (NCT06608238):: The SKNJCT-003 (NCT06608238) clinical study was designed as a randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. It was a multi-center study designed to enroll 90 participants presenting with nodular type basal cell carcinoma. The participants were randomized 1:1:1 into three groups: Device-controlled group receiving P-MNA Low-dose group receiving 100µg of D-MNA High-dose group receiving 200µg of D-MNA Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions. The Results from Pre-specified Expanded Analysis of 69 participants are summarized below: The expanded analysis demonstrates a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57. “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 Prog...

Medicus Pharma (NASDAQ:MDCX) has reported additional results from a pre-specified expanded dataset analysis of its Phase 2 SKNJCT-003 trial, showing a positive dose-response relationship for its Doxorubicin Microneedle Array (D-MNA) in treating nodular basal cell carcinoma (BCC). The analysis builds on previously disclosed topline results and incorporates biological, histologic, and safety data from a refined group of 69 patients whose diagnoses met the study’s intended inclusion criteria. The company said the findings may support future regulatory discussions with the US Food and Drug Administration as it advances the program. The randomized, double-blind, three-arm study evaluated two dose levels of D-MNA, 100 micrograms and 200 micrograms, against a device-only control in patients with nodular BCC. Participants were assessed at 29 and 57 days following treatment. According to the expanded analysis, outcomes improved over time and showed a dose-dependent pattern. At Day 57, the 200 microgram group demonstrated the highest response rates, with clinical clearance observed in 64% of patients and histological clearance in 55%. This compared with 44% and 33%, respectively, in the 100 microgram group, and 29% for both measures in the device-only arm. Earlier timepoint data at Day 29 showed more limited differentiation between groups, though the higher-dose cohort still recorded the strongest results. The company said the increasing separation by Day 57 supports a drug-driven therapeutic effect rather than a response attributable solely to the microneedle device. Medicus stated that the expanded dataset reinforces trends seen in prior analyses, including earlier Phase 1 findings and interim Phase 2 data, suggesting reproducibility across studies. The company added that the results provide a more precise view of treatment effect and may help guide future study design and endpoint selection ahead of end-of-Phase 2 regulatory discussions. Safety findings remained consistent with earlier reports. The treatment was generally well tolerated, with no drug-related serious adverse events or evidence of systemic doxorubicin toxicity. Reported side effects were primarily mild, localized reactions at the treatment site. The company noted that the device-only arm showed some early biological activity, potentially linked to a localized immune response, but did not demonstrate...

Advances Clinical Pipeline Across Dermatology, Urology, Oncology and strengthens Capital Base to support Phase 2 Programs PHILADELPHIA, PA / ACCESS Newswire / March 25, 2026 / 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 reported audited financial results for the year ended December 31, 2025, and provided a corporate update highlighting significant progress across its SkinJect® and Teverelix development programs, as well as expansion into precision medicine and AI-enabled clinical development. Management Commentary "2025 marked a pivotal year for Medicus, highlighted by completion of our Phase 2 SkinJect study, efforts to expand into rare disease and women's health indications, and the integration of agentic AI-driven clinical development capabilities." stated Dr. Raza Bokhari. Executive Chairman & CEO of Medicus "The strength of our clinical dataset, combined with regulatory alignment and potential access to capital resources, positions the Company to advance toward registrational planning and strategic partnerships in 2026 and beyond." SkinJect® Platform (Dermatology / Oncology / Rare Disease) SkinJect™, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing an ~$2 billion market opportunity. Skinject Phase 2 Positive Topline Dataset Highlights: The company completed a 90 patient Phase 2 clinical study, titled, "A randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma." The randomized design of SKNJCT-003, including a device-only active control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system. The Study positive Topline data demonstrated: Up to 73% clinical clearance in the highest dose cohort (200ug dose) continued biological activity between Day 29 and Day 57, supporting durability of response 200 ug cohort at Day 57 suggest ~3 out of 4 treated patie...

Phase 2 Study Demonstrated 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical intervention. PHILADELPHIA, PA / ACCESS Newswire / March 18, 2026 / 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, announced today that members of its executive management team, led by Dr. Raza Bokhari, Executive Chairman & CEO, will participate in a live fireside chat on Thursday, March 19, 2026, hosted by Kumaraguru (Kumar) Raja, Ph.D., Senior Biotechnology Analyst at Brookline Capital Markets. Dr. Bokhari will provide a company update including a review of the positive SkinJect® SKNJCT-003 Phase 2 clinical trial topline results that were reported earlier this month. Key findings of the study include 73% clinical Clearance in the 200-µg Arm suggests that ~3 out of 4 treated lesions may allow patients to avoid immediate surgical intervention. The SKNJCT-003 Phase 2 study is a "randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. Previously reported Topline results of the clinical clearance of study are tabulated below: Table 1. Clinical Clearance by Treatment Arm P-MNA: Microneedle device-only control arm D-MNA: Doxorubicin-loaded microneedle array The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort at Day 57, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma. The dataset reflects two complementary components of the SkinJect mechanism: Biological Activity of the Microneedle Device-Only Control (P-MNA) The SKNJCT-003 study included a microneedle device-only control arm (P-MNA) that did not contain the chemotherapeutic agent. Microneedle insertion into tumor tissue is known to produce localized biological activity, including: mechanical disruption of tumor architecture activation of wound-healing pathways localized immune signaling Basal cell carcinoma is recognized as a highly immunogenic tumor, and thes...

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce the company has released topline results from its Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of its Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of basal cell carcinoma of the skin. The company believes the topline data are not only positive but “decision-grade,” meaning they could support an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration in the first half of 2026 and help accelerate potential partnering discussions. Bokhari explained that the SKNJCT-003 clinical trial was designed as a randomized, double-blind, placebo-controlled, multi-center study involving 90 patients diagnosed with nodular basal cell carcinoma. The trial compared two dose levels of the D-MNA treatment with a placebo microneedle array control to assess both safety and therapeutic effectiveness. According to the results, clearance rates improved between Day 29 and Day 57, suggesting continued biological activity of the treatment over time. The higher-dose 200 microgram cohort demonstrated the strongest response by Day 57, achieving a 73% clinical clearance rate and a 40% histological clearance rate. The reported findings reflect analysis of the study’s primary and key secondary efficacy endpoints. Medicus Pharma noted that the final Clinical Study Report, which will include full safety analyses and additional procedural observations such as post-excisional biopsy site assessments, is still being compiled and is expected to be completed in the second quarter of 2026. While the final report remains in progress, the company said it does not anticipate any material changes to the efficacy findings reported in the topline results. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Biotech #CancerTreatment #ClinicalTrials #RazaBokhari #Biotech #ClinicalTrials #Phase2Trial #BasalCellCarcinoma #SkinCancer #Doxorubicin #MicroneedleArray #DrugDelivery #FDA #BiotechInnovation #MedicalResearch #CancerTreatment #HealthcareInnovation #Biopharma

Medicus Pharma (NASDAQ:MDCX) said on Thursday that its experimental microneedle-based therapy showed encouraging efficacy in a mid-stage clinical trial for treating Basal Cell Carcinoma, with the highest-dose group achieving 73% clinical clearance of lesions. The Phase 2 randomized, double-blind, placebo-controlled study enrolled 90 patients with nodular basal cell carcinoma and evaluated two doses of the company’s doxorubicin microneedle array (D-MNA), a non-invasive treatment designed to deliver chemotherapy through the skin. At 57 days after treatment, the 200-microgram dose group achieved 73% clinical clearance and 40% histological clearance confirmed by biopsy, according to a statement from Medicus. In comparison, the placebo group recorded clinical clearance of 38% and histological clearance of 38% at the same timepoint. The trial also included a 100-microgram dose group, which achieved clinical clearance of 42% and histological clearance of 33% at Day 57. The company said clearance rates increased between the first evaluation at Day 29 and the later assessment at Day 57, suggesting continued biological activity of the therapy over time. “We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level,” said CEO Dr Raza Bokhari. “The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. Importantly, we believe this dataset strengthens our position in ongoing and prospective partnering discussions and may accelerate strategic engagement as we evaluate optimal pathways for value creation.” The company said the results could support an end-of-Phase-2 meeting with the U.S. Food and Drug Administration in the first half of 2026. Medicus added that the full clinical study report, including safety analyses and additional procedural observations, is expected to be completed in the second quarter of 2026, and the company does not anticipate material changes to the reported efficacy findings. The trial was not designed as a registrational study, and the company cautioned that the results do not guarantee regulatory approval. Medicus said i...

Clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next generation GnRH antagonist, are steadily advancing PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 14, 2025 / 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 therapeutic assets, announced today its financial and operating results for the quarter ending September 30, 2025, and highlighted important corporate updates. Third Quarter Corporate Highlights: Skinject Clinical Development Program SKNJCT-003 & SKNJCT-004 Progress: The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States. SKNJCT-003, which commenced randomizing patients in August 2024, is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable doxorubicin-containing microneedle arrays (D-MNA). In August 2025, the Company announced that SKNJCT-003 has randomized more than seventy-five percent (75%) of the ninety (90) participants expected to be randomized in the study. In September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of SkinJect, indicating that the Company may follow the FDA's 505(b)(2) regulatory pathway to non-invasively treat BCC of the skin using dissolvable D-MNA. In October 2025, the Company treated its first patient in the clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi is the principal investigator. 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 P...

US Food and Drug Administration (FDA) has accepted the company's Type C meeting request and SKNJCT-003 Phase 2 study has randomized more than 75% of patients Philadelphia, Pennsylvania--(Newsfile Corp. - August 21, 2025) - 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 therapeutic assets, is pleased to announce, following the acceptance of the Type C meeting request by the United States Food and Drug Administration (the "FDA"), the Company has submitted its queries in writing and expect to receive a response from the FDA before the end of Q3 2025. The purpose of the Type C meeting is to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. The Company's aim is to gain the FDA's consent to fast-track the clinical development program and seek feedback on future clinical plans for the D-MNA development program. The Company also announced that its phase 2 clinical study to non-invasively treat BCC using novel D-MNA (SKNJCT-003) has now randomized more than seventy five percent (75%) of the ninety (90) participants expected to be randomized in the study. Clinical Trial Design The clinical study (SKNJCT-003) is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study originally enrolling up to sixty (60) subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study al...

The Company added Congresswoman Cathy McMorris Rodgers & Ajay Raju, Esq. to the Board of Directors. Philadelphia, Pennsylvania--(Newsfile Corp. - July 23, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce the voting results of the Company's annual and special meeting (the "Meeting") of shareholders that was held on July 22, 2025, at 10:00 a.m. (Eastern Time), at the law offices of Bennett Jones in Toronto, Ontario. The Company's shareholders passed all the resolutions put before them. At the Meeting, all eight nominees for the board of directors of the Company were elected, the voting results of which are as follows: "The shareholders of the company are proud to elect and re-elect a balanced, diverse, entrepreneurial and experienced leadership in drug development, good governance, capital markets and mergers & acquisitions," stated Dr. Raza Bokhari, Executive Chairman & CEO. "We are honored to welcome the Honorable Cathy McMorris Rodgers and Ajay Raju to the board. Ajay's contributions as a thought leader, opinion maker, and an emerging disruptor in the life sciences and biotech sector in the keystone region are noteworthy; his seed investment of $8M in our pre-IPO round was pivotal to get us off the ground." Dr. Bokhari also highlighted Congresswoman Rodgers's distinguished record of public service. "Cathy, as a law maker for three decades, broke the glass ceiling to become the first female Chair of the powerful House Committee on Energy & Commerce, where she had jurisdiction over 80% of the U.S. economy, including energy production, telecommunication, internet, interstate commerce, healthcare and Food and Drug Safety." Dr. Bokhari proudly announced, "We couldn't be more fortunate to be Congresswoman's first choice as she sought election as a board member, following her retirement from the U.S. Congress in 2024." New Board Members Hon. Cathy McMorris Rodgers The Honorable Cathy McMorris Rodgers is a trailblazer and dedicated public servant who has spent three decades serving her state and country. She served as the U.S. Representative for Washington's 5th Congressional District from 2004 to 2025. As a high-profile congressional leader, innovative policymaker, and trust-builder, she is regarded as a unifying force and a high-impact leader with a long history of accomplishments. Cathy is people-centric, guided by v...