Medicus Pharma Ltd. Explore Novel Treatment Innovations that may Revolutionize Treatments for Prostate and Skin Cancers
Rhea-AI Summary
Medicus Pharma (Nasdaq: MDCX) announced clinical and corporate developments on Nov 24, 2025 focused on next‑generation prostate and skin cancer therapies.
Key points: Acquisition of Antev (Aug 2025) advancing Teverelix, a long‑acting GnRH antagonist with Phase 2a data showing 97.5% probability of castrate testosterone suppression (50 patients) and prior FDA written guidance supporting Phase 3 design. The company also reports SkinJect™ microneedle program progress: Phase 1 safety with 6 complete histologic responses (March 2021), ongoing SKNJCT‑003/004 trials, UK regulatory approvals to expand SKNJCT‑003 (Nov 2025), and a GSA collaboration for Expanded Access IND (Oct 2025).
Positive
- Acquired Antev in Aug 2025
- Teverelix Phase 2a: 97.5% probability of castrate testosterone suppression
- FDA provided written guidance supporting proposed Phase 3 design
- UK MHRA/HRA/WREC approvals to expand SKNJCT‑003 in Nov 2025
- Phase 1 SkinJect: 6 complete histologic responses (Mar 2021)
Negative
- Teverelix secondary endpoint fell to 82.5% probability by Day 42
- MoU with HelixNano is non‑binding and does not obligate collaboration
- SKNJCT‑003 is exploratory; conversion to pivotal is not guaranteed
Insights
Medicus advances two clinical programs with regulatory approvals and a strategic acquisition, but mixed phase results warrant cautious interpretation.
Medicus completed the acquisition of Antev and inherited Teverelix, a long-acting GnRH antagonist formulated for six-week dosing that showed rapid testosterone suppression in Phase 1 and achieved
Key risks remain: the Phase 2a secondary endpoint fell to
Watch near-term milestones: the ongoing Phase 2b studies and any announced Phase 3 design or initiation, along with results showing sustained castration past Day 42; expect meaningful updates within typical clinical timelines for each trial phase (months to a few years).
SkinJect shows translational progress with safety data, expanded approvals in the U.K., and an Expanded Access initiative for rare disease patients.
SkinJect completed a Phase 1 safety study with six complete histologic responses and is running randomized double-blind multicenter trials SKNJCT-003 and SKNJCT-004 across the U.S., Europe and UAE; the Company obtained full U.K. regulatory and ethics approvals to expand SKNJCT-003 and announced a collaboration with the Gorlin Syndrome Alliance to pursue an Expanded Access IND.
Dependencies include confirmatory efficacy in the ongoing randomized studies and regulatory acceptance of real-world safety data collected under the Expanded Access IND. The announced compassionate-access framework may accelerate patient access and generate safety data, but it does not replace randomized efficacy evidence.
Concrete near-term items to monitor: enrollment progress and interim safety/efficacy readouts from SKNJCT-003/SKNJCT-004, any FDA responses regarding Expanded Access IND submissions, and the outcome of the non-binding MoU with HelixNano; expect updates over the next several quarters as sites enroll and regulators review submissions.
PHILADELPHIA, Nov. 24, 2025 (GLOBE NEWSWIRE) -- November is Men’s Health Awareness Month, a time to spotlight the latest medical breakthroughs that may transform how we detect and treat cancer– especially prostate and skin cancer, which are among the most common cancers affecting men.
In advanced prostate cancer, lifelong treatment modalities are making a difference, yet challenges remain for patients with a high cardiovascular risk profile linked to hormone deprivation therapies.
“While hormone deprivation therapy has long been the standard for advanced prostate cancer, most of the drugs in this category can raise cardiovascular risks,” explained Dr. Raza Bokhari, Executive Chairman & CEO of Medicus Pharma. Ltd (Nasdaq: MDCX). “Medicus Pharma is developing next-generation hormone deprivation therapies for advanced stage prostate cancer that may protect the heart while effectively controlling the cancer.”
A Media Snippet accompanying this announcement is available by clicking on this link.
Similarly, in skin cancer – particularly in basal cell carcinoma, which is the most common cancer with 5 million new cases every year in United States – the only effective treatment is Mohs surgery, which is painful, expensive, aesthetically not very pleasing, and not available to everyone.
Researchers at Carnegie Mellon and University of Pittsburgh have designed a patented dissolvable microneedle patch to deliver a chemotherapeutic agent directly to the site of the lesion. It triggers an immune response that can kill cancer cells, eliminating the need for expensive and painful surgery.
“This new dissolvable microneedle skin patch delivers chemotherapy directly to the lesion, offering a non-surgical, more accessible and patient-friendly option that could transform future skin cancer care,” said Dr. Bokhari.
For more information on new developments in prostate and skin cancer treatment, the connection between heart health and hormone therapy and how innovation is leading to more patient-friendly options, visit MedicusPharma.com.
For further information contact:
Carolyn Bonner, President and Acting 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 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, spread over three continents.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., 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. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "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 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.
Antev’s flagship drug candidate is Teverelix trifluoroacetate, a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. 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 September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than
In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev’s proposed Phase 3 trial design for Teverelix. This milestone supports the Company’s clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.
In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.
In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients
In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) 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 Food and Drug Administration (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 Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (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 U.K. Good Clinical Practice and National Health Service capacity and capability standards.
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, 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 and high CV risk prostate cancer, 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 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.
FAQ
What does Medicus Pharma's acquisition of Antev (Aug 2025) mean for MDCX shareholders?
What were Teverelix's Phase 2a results reported by Medicus Pharma (MDCX)?
What regulatory progress did Medicus Pharma announce for SkinJect™ on Nov 24, 2025?
How many complete responses were reported in SkinJect's Phase 1 study and when?
What is the status of Medicus Pharma's Expanded Access plans for SkinJect and Gorlin Syndrome?
Is Medicus Pharma's MoU with Helix Nanotechnologies binding for MDCX investors?
