Press Releases June 22, 2026 07:30 AM

Medicus Pharma to Showcase SkinJect® Registrational Strategy and Teverelix® Precision Medicine Program at Bio International 2026

Medicus Pharma highlights key clinical advancements and regulatory strategies for SkinJect® and Teverelix® at Bio International 2026 Conference

By Hana Yamamoto
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MDCX

Medicus Pharma Ltd., a Nasdaq-listed biotech company, announced its participation in the 2026 Bio International Conference to present advancements in its clinical development programs for SkinJect®, an innovative treatment for basal cell carcinoma and Gorlin Syndrome, and Teverelix®, a next-generation GnRH antagonist targeting prostate cancer, acute urinary retention relapse, and endometriosis. Updates include positive Phase 2 data for SkinJect®, ongoing FDA interactions, and a new precision medicine study leveraging genome profiling. The company is focused on de-risking Phase 2 programs to attract strategic partnerships and eventual commercialization.

Medicus Pharma to Showcase SkinJect® Registrational Strategy and Teverelix® Precision Medicine Program at Bio International 2026
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Key Points

  • SkinJect® Phase 2 data shows promising efficacy with 55% histological and 64% clinical clearance rates in basal cell carcinoma patients, supporting plans for registrational development and seeking orphan and rare pediatric designations.
  • Teverelix® is advancing multiple clinical programs, including a Phase 2b prostate cancer dose-optimization study and a novel Phase 2a precision medicine study for endometriosis based on genomic profiling in collaboration with the UAE Genome Program.
  • Medicus emphasizes Phase 2 de-risking to enhance strategic partnering opportunities, addressing significant unmet medical needs in oncology, urology, and women's health sectors.

PHILADELPHIA, June 22, 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 therapeutic assets, today announced that it will participate in the 2026 Bio International Conference, being held on June 22-25, 2026, in San Diego, California.

Dr. Faisal Mehmud, Chief Medical Officer of Medicus, will deliver a company presentation highlighting recent clinical, regulatory and strategic advancements across the Company’s development portfolio.

The presentation will provide updates on SkinJect®, an investigational Doxorubicin containing dissolvable micro-needle arrays (D-MNA) designed to non-invasively treat basal cell carcinoma (BCC) of the skin. The Company will discuss the positive decision-grade dataset recently reported from the Phase 2 SKNJCT-003 study, which demonstrated a clear dose-response relationship and clinically meaningful complete response rates (55% histological clearance and 64% clinical clearance) in patients treated with SkinJect® 200 ug cohort. Dr. Mehmud will also provide an update on the ongoing interactions with the U.S. Food and Drug Administration (FDA) previously disclosed by the Company, preparation for upcoming SKNJCT-003 End-of-Phase 2 meeting, the planned registrational development strategy, and regulatory initiatives supporting SkinJect® in Gorlin Syndrome, including orphan drug and rare pediatric disease designation requests currently under FDA review.

The Company’s presentation will also provide updates on recent advances across Teverelix®, a next-generation GnRH antagonist, including the advanced prostate cancer program, the acute urinary retention relapse (AURr) program, and the recently initiated PRECISION-E2 Phase 2a study in endometriosis leveraging the United Arab Emirates (UAE) Genome Program. The study is designed to generate one of the first prospective datasets integrating genomic profiling with hormonal modulation in women with endometriosis, potentially supporting a precision medicine approach to patient selection and treatment optimization.

Bio International Presentation Details

Presentation Date:Wednesday, June 24, 2026Time:3:00 p.m. Pacific timeLocation:Theater 2, San Diego Convention Center  

Medicus’ key development programs are:

SkinJect®, a novel localized immuno-oncology precision product is a novel lesion-directed therapeutic platform designed to deliver doxorubicin directly into basal cell carcinoma lesions through a proprietary dissolvable microneedle array. The program has completed Phase 2 development in nodular basal cell carcinoma and is being advanced toward registrational development in nodular basal cell carcinoma, as well as in Gorlin Syndrome, a rare genetic disorder characterized by the development of multiple and recurrent basal cell carcinomas often beginning in early childhood.

The Company recently submitted to the FDA a request for Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for SkinJect® to treat recurrent BCC lesions in patients with Gorlin Syndrome, both of which remain under review. Medicus believes SkinJect® has the potential to become the first FDA-approved lesion-directed therapy specifically developed for patients with Gorlin Syndrome, a population with significant unmet medical need and limited treatment options. If granted and ultimately supported by regulatory approval, these programs may provide important regulatory incentives, including market exclusivity and potential expedited review benefits.

Teverelix®, a next-generation GnRH antagonist, is being developed across multiple indications, including advanced prostate cancer, acute urinary retention relapse (AURr) primarily due to enlarged prostate, and endometriosis.

In advanced prostate cancer, Medicus recently announced the submission of a substantial modification application through the European Union Clinical Trials Information System (CTIS) supporting a planned Phase 2b dose-optimization study intended to support future registrational development. The Company’s broader development strategy is focused on addressing the needs of advanced prostate cancer patients with elevated cardiovascular risk, an area where significant unmet medical need remains.

In urology, Medicus continues to advance Teverelix® for the prevention of recurrent acute urinary retention following successful catheter removal, a setting for which there are currently no approved therapies specifically indicated to prevent recurrence.

In women’s health, the Company recently initiated the PRECISION-E2 Phase 2a study evaluating Teverelix® in women with moderate-to-severe endometriosis through a collaboration leveraging the UAE Genome Program, one of the world's most comprehensive national genomic initiatives. The study is intended to identify genetic signatures associated with treatment response and disease biology, potentially enabling a precision medicine framework for future endometriosis management.

Medicus Strategic Focus on Phase 2 De-Risking and Partnering

Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept, key clinical and regulatory inflection points that substantially reduce development risk and increase attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
[email protected]  

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
[email protected]

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.

The Company’s current key therapeutic assets are:

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.

Teverelix®, a next-generation GnRH antagonist, is a product under clinical development for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, and endometriosis.

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, statements regarding the development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome the submission of Protocol SKNJCT-005 and the design, timing, conduct and results of the SKNJCT-005 Phase 2b registrational study, including whether the resulting data will be sufficient to support a future New Drug Application for SkinJect® in Gorlin Syndrome, the potential for SkinJect® to become the first FDA-approved lesion-directed therapy for patients with Gorlin Syndrome and a new standard of care for this patient population; and the potential issuance and benefits of a Rare Pediatric Disease Priority Review Voucher if the Company’s submission request is approved, Orphan drug designation for SkinJect®, the development of Teverelix® and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the development, advancement and commercialization of SkinJect® through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectations regarding reported efficacy findings of SkinJect®. 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, 2025, 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.


Risks

  • SkinJect® regulatory approvals, including orphan drug and rare pediatric disease designations, are still under FDA review, creating uncertainty around accelerated development and market exclusivity benefits.
  • Clinical trial outcomes, especially for planned Phase 2b and Phase 2a studies of Teverelix®, remain uncertain and could affect the development timeline and potential efficacy claims.
  • Broad risks include market adoption challenges upon approval and the inherent unpredictability of biotech product development and regulatory pathways, impacting financial performance and stock price.

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