Medicus Pharma Ltd. Announces Filing of FDA Commissioner’s National Priority Voucher Application (CNPV) for SKNJCT-003 to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin

Rhea-AI Summary

Medicus Pharma (NASDAQ: MDCX) announced it filed a FDA Commissioner’s National Priority Voucher (CNPV) application on Nov 17, 2025 for SkinJect’s SKNJCT-003, a dissolvable doxorubicin microneedle array (D-MNA) to non-invasively treat basal cell carcinoma (BCC).

Key program facts: SKNJCT-003 is a randomized, double-blind Phase 2 trial (started Aug 2024) expanded to 90 subjects, reported a March 2025 interim showing >60% clinical clearance (preliminary), and received positive FDA Type C feedback on a 505(b)(2) pathway in Sept 2025. The company received UK regulatory and ethics approvals in Nov 2025 and began SKNJCT-004 in UAE (36 patients).

Positive

• CNPV application filed on Nov 17, 2025
• Phase 2 interim showed >60% clinical clearance (March 2025)
• Study enrollment increased to 90 subjects (April 2025)
• UK MHRA/HRA/WREC full approvals received (November 2025)
• SKNJCT-004 initiated in UAE to randomize 36 patients

Negative

• Interim results are preliminary and may not correlate with final study outcomes
• CNPV supply is limited; voucher allocation is not guaranteed
• Teverelix Phase 2a secondary endpoint dropped to 82.5% by Day 42 (Feb 2023)

Insights

Regulatory & Clinical Strategist

Medicus submitted a CNPV application for SKNJCT-003, showing regulatory engagement and multicountry clinical progress.

SKNJCT-003 is a Phase 2 program evaluating a doxorubicin-containing dissolvable microneedle array (D-MNA) to treat basal cell carcinoma; the company submitted a Commissioner’s National Priority Voucher (CNPV) application on November 17, 2025 to seek expedited, commissioner-led review. The program has multiple regulatory touchpoints: positive FDA Type C feedback suggesting a 505(b)(2) pathway, U.K. MHRA/HRA/WREC approvals to expand the Phase 2 study, and an ongoing Phase 2 in nine U.S. sites plus a separate SKNJCT-004 trial in the UAE with the first patient treated in October 2025.

Key factual milestones support the filing: an interim analysis in March 2025 showed greater than 60% clinical clearance (preliminary), the U.S. study enrollment was increased from 60 to ninety (90) participants and later surpassed 75% randomization, and the company announced a collaboration with the Gorlin Syndrome Alliance to pursue an Expanded Access IND. These elements together justify claiming alignment with CNPV criteria: public-health impact, unmet need, access, affordability, domestic manufacturing, and rare-disease relevance.

Dependencies and risks are concrete and limited to disclosed facts: the interim result is explicitly preliminary and may not represent final outcomes, and CNPVs are limited in number in the program’s first year. Watch for the completed Phase 2 readout, final histopathologic cure rates, formal FDA decision on CNPV inclusion, and any accelerated approval determination; expect relevant updates over the next 6–18 months as trials complete and regulatory reviews proceed.

SKNJCT-003 Doxorubicin containing Microneedle Array (D-MNA) clinical development program to non-invasively treat BCC aligns with national priorities of public health impact, unmet medical need, access, affordability, domestic manufacturing and rare-disease alignment

PHILADELPHIA, Nov. 17, 2025 (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, is pleased to announce that it has submitted an FDA Commissioner’s national priority voucher (CNPV) application on behalf of Skinject (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The submission includes a complete Statement of Interest outlining SkinJect’s alignment with FDA national priorities in cancer care access, affordability, and rare-disease needs.  

On June 17, 2025, FDA Commissioner Marty Makary, MD, MPH announced a new approval pathway, the Commissioner's National Priority Voucher (CPNV) for approval of drugs to enhance the health interests of Americans. Previously, on May 25 he identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority. The new voucher may be redeemed by drug developers to participate in a commissioner-led program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission.  The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.

The FDA plans, in the first year of the program, to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of addressing a health crisis in the U.S., delivering more innovative cures for the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue.

The Company believes it meets each of the above criteria and seeks inclusion in the CNPV Pilot Program to enable enhanced FDA collaboration and expedited review, accelerating access to a U.S.-developed, cost-effective, cancer therapy that supports national goals of improving access, safety, and quality of care and providing access to Gorlin Syndrome patients that have no available treatment.

“We believe that SkinJect’s D-MNA is uniquely positioned to expand access to effective non-melanoma skin cancer treatment, especially BCC, while dramatically reducing healthcare costs and surgical dependence,” stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO. “Our CNPV submission emphasizes not only SkinJect’s broad public-health value but also its profound potential impact on patients with Gorlin syndrome, who often endure hundreds of surgeries in their lifetime. We believe SkinJect represents the type of U.S.-developed, patient-centered innovation that the FDA’s CNPV program is designed to accelerate; a non-surgical, low-cost innovation for America’s most common cancer.”

Skinject Alignment with National Priorities:

SkinJect directly addresses a significant U.S. public-health priority by offering a non-surgical, locally administered therapy for basal cell carcinoma—the most common cancer in the United States, with over five million new cases each year. Current standard treatment, Mohs micrographic surgery, is costly, invasive, and often inaccessible to elderly or medically fragile patients. SkinJect’s biodegradable microneedle patch offers a curative, office-based alternative that eliminates the need for Mohs surgery.

There are more than seven million patients with BCC waiting in the queue for a treatment opportunity, highlighting a significant un-met medical need.

Program Description:

SkinJect is a single-use, dissolvable microneedle array (D-MNA) that delivers a localized therapeutic agent directly into the lesion site. The patch biodegrades after drug delivery, requiring no surgical intervention. The current clinical program, SKNJCT-003, under IND 139837 is evaluating lesion clearance rate, histopathologic cure, and patient tolerability in nodular type of BCC. Its low-cost, minimally invasive design supports broad access.

Public-Health Impact and Priority Justification:

This program fulfills multiple CNPV criteria:

• Addresses a U.S. health crisis by reducing the burden of skin cancer care and surgical dependence.
• Addresses a large unmet medical need for non-surgical, curative BCC therapy.
• Improves affordability and access through an office-based administration.
• Supports domestic manufacturing of microneedle components and drug formulation.

Rare Disease Consideration – Gorlin Syndrome:

SkinJect also addresses the urgent unmet needs of patients with Gorlin syndrome (basal cell nevus syndrome), a rare genetic disorder affecting 1 in 31,000 people worldwide in which individuals develop hundreds of recurrent BCCs over their lifetime, often beginning in early childhood. These patients face repeated surgeries, scarring, and psychological burden. A minimally invasive, D-MNA therapy capable of eradicating BCC lesions could transform management for this population that endure lifelong burden of recurring BCC.

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 March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.

In April 2025, the investigational review board approved to increase the number of participants in SKNJCT-003 to ninety (90) subjects.

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 commenced clinical study (SKNJCT-004) in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE with Cleveland Clinic Abu Dhabi (CCAD) as the principal investigator. Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.

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).

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 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.

Skinject Platform Expansion:

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, to explore co-development of thermostable infectious disease vaccines.

Pipeline Expansion—Acquisition of Antev

In August 2025, the Company completed the acquisition of Antev Limited (“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.

Patient Access & Advocacy—Gorlin Syndrome Alliance Collaboration

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 FDA to allow patients with multiple, recurrent, or inoperable BCCs of the skin 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.

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 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by Day 42.

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 did Medicus Pharma (MDCX) file with the FDA on November 17, 2025?

Medicus filed a CNPV application for SKNJCT-003, seeking expedited commissioner-led review for the SkinJect D-MNA BCC therapy.

What are the SKNJCT-003 Phase 2 trial results reported by MDCX as of March 2025?

An interim analysis in March 2025 showed preliminary >60% clinical clearance after >50% of the then-targeted patients were randomized.

How many patients will SKNJCT-003 enroll after the April 2025 amendment?

The trial enrollment was increased to 90 subjects following IRB approval in April 2025.

What regulatory feedback did MDCX receive from the FDA in September 2025 for SkinJect?

The FDA provided positive feedback in a Type C meeting indicating SkinJect may follow a 505(b)(2) regulatory pathway.

What is the scope of the SKNJCT-004 study that MDCX began in 2025?

SKNJCT-004 commenced in September 2025 in the UAE and is expected to randomize 36 patients across six sites.

Did Medicus receive approvals to expand SKNJCT-003 into the U.K.?

Yes; in November 2025 the company received MHRA, HRA, and Wales Research Ethics Committee approvals to expand SKNJCT-003 in the U.K.

What does the CNPV application mean for MDCX shareholders (MDCX)?

The application seeks inclusion in a pilot program that could shorten FDA review to 1–2 months if a voucher is granted and conditions are met.