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

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Medicus Pharma (NASDAQ:MDCX) will present at Bio International 2026 in San Diego on June 24, 2026, at 3:00 p.m. Pacific in Theater 2.

The presentation will cover SkinJect® Phase 2b strategy in Gorlin Syndrome and Teverelix® programs in advanced prostate cancer, AURr, and endometriosis, including the PRECISION-E2 genomic study.

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News Market Reaction – MDCX

-1.86%
4 alerts
-1.86% Session close to close
-16.5% Trough Tracked
$26.64M Market Cap
0.3x Rel. Volume

In the Jun 22 session, MDCX declined 1.86%, reflecting a mild negative market reaction. Argus tracked a trough of -16.5% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement consolidates Phase 2 progress for SkinJect and Teverelix, highlighting decision-gr...
Analysis

This announcement consolidates Phase 2 progress for SkinJect and Teverelix, highlighting decision-grade data and upcoming FDA interactions. Investors should watch designations and registrational trial starts, while weighing balance-sheet constraints and historically volatile reactions to regulatory updates.

Key Figures

Histological clearance: 55% Clinical clearance: 64%
2 metrics
Histological clearance 55% Phase 2 SKNJCT-003 SkinJect 200 ug cohort
Clinical clearance 64% Phase 2 SKNJCT-003 SkinJect 200 ug cohort

Historical Context

5 past events · Latest: Jun 15 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 15 RPDD submission Positive -5.2% Filed Rare Pediatric Disease Designation request for SkinJect in Gorlin Syndrome.
Jun 11 Endometriosis trial launch Positive +4.0% Initiated PRECISION-E2 Phase 2a Teverelix study using Emirati Genome Program.
Jun 08 Prostate cancer study Positive -3.1% EU submission to support Phase 2b Teverelix trial in high CV-risk prostate cancer.
Jun 03 Gorlin Phase 2b Positive +7.0% Submitted SKNJCT-005, advancing SkinJect into Phase 2b registrational study in Gorlin.
May 28 Non-dilutive financing Positive +6.7% Entered up to $22M non-dilutive structured financing, extending operating cash runway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

MDCX often reacts positively to clear de-risking or financing milestones, but regulatory and designation updates have produced mixed price responses.

Key Terms

orphan drug designation, rare pediatric disease designation, gnrh antagonist, precision medicine, +2 more
6 terms
orphan drug designation regulatory
"including orphan drug and rare pediatric disease designation requests currently under FDA review"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
rare pediatric disease designation regulatory
"request for Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for SkinJect"
A rare pediatric disease designation is an official regulatory status given to a drug or therapy that targets a serious or life‑threatening condition primarily affecting children and is uncommon in the population. It matters to investors because the status often brings financial and development perks — such as tax credits, reduced fees, faster review and periods of market protection — which can lower costs, speed approval and improve the commercial outlook; think of it as a VIP pass that makes bringing a scarce, child‑focused treatment to market easier and potentially more profitable.
gnrh antagonist medical
"Teverelix®, a next-generation GnRH antagonist, is being developed across multiple indications"
A GnRH antagonist is a type of medicine that blocks the body’s chemical switch that tells the ovaries or testes to make sex hormones like estrogen or testosterone. Like turning off a faucet that controls hormone flow, this immediate block lowers hormone levels and is used in conditions such as hormone-driven cancers and fertility treatments. Investors follow GnRH antagonists for their potential market size, regulatory approvals, and how they fit into a drug maker’s pipeline and revenue outlook.
precision medicine medical
"potentially supporting a precision medicine approach to patient selection and treatment optimization"
Precision medicine uses a person’s unique genetic makeup, lifestyle and environment to choose treatments and preventive steps that are more likely to work for them than one-size-fits-all approaches. For investors, it matters because it can make therapies more effective and efficient—think tailoring a suit rather than buying off the rack—affecting drug development costs, market size, pricing power and the speed at which therapies win regulatory approval.
end-of-phase 2 meeting regulatory
"preparation for upcoming SKNJCT-003 End-of-Phase 2 meeting, the planned registrational development strategy"
An end-of-phase 2 meeting is a formal discussion between a drug developer and a regulatory agency to review mid-stage clinical results and agree on the plan and requirements for the larger, final tests needed for approval. It matters to investors because the meeting can clarify what evidence regulators will require, shape the cost and timeline for the next phase, and reduce uncertainty about whether a drug can advance toward market — like a checkpoint that determines whether a project gets the green light to move to the next, expensive stage.
priority review voucher regulatory
"potential issuance and benefits of a Rare Pediatric Disease Priority Review Voucher if the Company’s submission request is approved"
A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company’s presentation will provide updates on SkinJect® Phase 2b Pivotal Study in patients with Gorlin Syndrome and Teverelix® Groundbreaking PRECISION-E2 Phase 2a Endometriosis Study leveraging the UAE Genome Program

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, 2026
Time:3:00 p.m. Pacific time
Location: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
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 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.


FAQ

What will Medicus Pharma (MDCX) present at Bio International 2026?

Medicus Pharma will present clinical and regulatory updates on SkinJect® and Teverelix® programs. According to Medicus, topics include SkinJect® Phase 2b planning in Gorlin Syndrome and Teverelix® development in advanced prostate cancer, acute urinary retention relapse, and endometriosis.

When and where is Medicus Pharma’s (MDCX) Bio International 2026 presentation?

Medicus Pharma presents on Wednesday, June 24, 2026, at 3:00 p.m. Pacific time. According to Medicus, the session will take place in Theater 2 at the San Diego Convention Center during the Bio International 2026 conference.

What SkinJect clinical data will Medicus Pharma (MDCX) highlight at Bio International 2026?

Medicus Pharma plans to discuss SkinJect® Phase 2 SKNJCT-003 dose-response and clearance rates. According to Medicus, the 200 µg cohort showed 55% histological clearance and 64% clinical clearance in basal cell carcinoma, supporting a planned Phase 2b registrational strategy in Gorlin Syndrome.

How is Medicus Pharma (MDCX) advancing Teverelix for endometriosis in 2026?

Medicus Pharma is running the PRECISION-E2 Phase 2a Teverelix® study in moderate-to-severe endometriosis. According to Medicus, the trial leverages the UAE Genome Program to link genomic profiles with hormonal modulation, aiming to support a precision medicine approach to future endometriosis treatment.

What are the key Teverelix development programs Medicus Pharma (MDCX) will discuss?

Medicus Pharma will review Teverelix® programs in advanced prostate cancer, AURr, and endometriosis. According to Medicus, activities include an EU CTIS submission for a planned Phase 2b prostate cancer study and continued work preventing recurrent acute urinary retention after catheter removal.

How is Medicus Pharma’s (MDCX) strategy focused on Phase 2 de-risking and partnering?

Medicus Pharma aims to advance assets through Phase 2 proof-of-concept and regulatory inflection points. According to Medicus, it seeks decision-grade datasets to support strategic collaborations, regional licensing, and commercialization partnerships while maintaining capital efficiency and focusing on SkinJect® and Teverelix®.