Medicus Pharma Receives UAE Department of Health (DOH) Authorization to proceed with Novel Prospective Genomics Guided Precision Medicine Study Evaluating Teverelix® in Women with Endometriosis
Rhea-AI Summary
Medicus Pharma (NASDAQ: MDCX) received Investigational New Drug authorization from the UAE Department of Health – Abu Dhabi for its randomized, placebo-controlled Phase 2a PRECISION-E2 clinical study of Teverelix® in approximately 84 women with moderate-to-severe symptomatic endometriosis. The DOH authorization follows a comprehensive review of chemistry, manufacturing and controls, non-clinical, clinical and safety data and allows the study to proceed, subject to site-specific IRB and ethics approvals.
PRECISION-E2 will test multiple Teverelix® doses and routes versus placebo, focusing on maintaining serum estradiol in the Barbieri therapeutic window for at least 14 consecutive days, while integrating pharmacodynamic, pharmacokinetic, biomarker, clinical and whole-genome data to explore candidate treatment-response biomarkers for future precision medicine strategies in women’s health.
Positive
- DOH Abu Dhabi IND authorization for PRECISION-E2 Phase 2a Teverelix® study in endometriosis
- Approximately 84 patients in randomized, placebo-controlled, multi-arm Phase 2a design
- Primary estradiol endpoint based on Barbieri therapeutic window over 14 consecutive days
- Prospective genomics integration including whole-genome data and predefined gene panels
- Multi-indication development of Teverelix® across prostate cancer, AURr and endometriosis
Negative
- Study start still subject to IRB and ethics approvals at each site
- Any biomarker or gene signature from PRECISION-E2 requires confirmation in later studies before use
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 27 | FDA study authorization | Positive | -14.0% | FDA allowed registrational SkinJect study to proceed with protocol enhancements and extended follow-up |
| Jul 16 | Phase 2 trial approval | Positive | +16.5% | FDA feedback and central IRB approval enabled optimized Teverelix acute urinary retention study |
| Jun 22 | Investor presentation | Neutral | -1.9% | Company presentation covered SkinJect strategy and Teverelix precision medicine programs |
| Jun 15 | FDA designation request | Positive | -5.2% | Company submitted Rare Pediatric Disease Designation request for SkinJect in Gorlin Syndrome |
| Jun 11 | IND submission | Positive | +4.0% | Company submitted IND for PRECISION-E2 endometriosis trial in the United Arab Emirates |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive regulatory and clinical announcements produced mixed historical reactions, including two divergent declines and two aligned gains.
Key Terms
investigational new drug regulatory
chemistry, manufacturing and controls regulatory
pharmacodynamics medical
pharmacokinetic medical
immunogenicity medical
GnRH antagonist medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Randomized Phase 2a PRECISION-E2 study designed to evaluate a predefined panel of genes to advance personalized medicine in women's health
PHILADELPHIA, July 31, 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 the United Arab Emirates (UAE) Department of Health – Abu Dhabi ("DOH") has granted Investigational New Drug ("IND") authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix® in women with moderate-to-severe symptomatic endometriosis, a chronic estrogen-dependent inflammatory disease that affects approximately one in ten women of reproductive age worldwide.
The authorization follows completion of the DOH's comprehensive scientific and regulatory review of the Company's chemistry, manufacturing and controls (CMC), non-clinical, clinical and safety documentation and approved the “Study to Proceed”, subject to completion of required site-specific Institutional Review Board ("IRB") and ethics approvals.
The PRECISION-E2 study represents a significant regulatory milestone in Medicus' women's health strategy and advances the development of Teverelix® into what the Company believes is one of the first prospective genomics-guided precision medicine development programs designed to identify women with moderate-to-severe endometriosis most likely to benefit from a long-acting GnRH antagonist.
"Today's IND authorization represents far more than approval to initiate another clinical study,” stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO, "it validates a development strategy designed to combine precision endocrinology, pharmacology and population genomics within a prospective clinical trial. We believe PRECISION-E2 has the potential not only to optimize the future development of Teverelix® but also is an important step toward personalized therapy that could help redefine how women with endometriosis and other estrogen-driven diseases are stratified and may support future development across multiple women's health indications.”
PRECISION-E2 Study Design:
PRECISION-E2 (Precision Estradiol Suppression and Genomic Response Study in Endometriosis) is a prospective, randomized, placebo-controlled Phase 2a clinical study designed to evaluate the pharmacodynamics, safety, tolerability, clinical activity and exploratory genomic correlates of Teverelix® in approximately 84 women with moderate-to-severe symptomatic endometriosis across multiple investigational sites in the United Arab Emirates.
Participants will be randomized equally among four treatment groups:
- Teverelix® 60 mg administered subcutaneously
- Teverelix® 90 mg administered subcutaneously
- Teverelix® 90 mg administered intramuscularly
- Placebo administered subcutaneously.
The study's primary pharmacodynamic endpoint is the proportion of participants achieving and maintaining serum estradiol within the established Barbieri therapeutic window (approximately 20–50 pg/mL) for at least 14 consecutive days following treatment.
Secondary and exploratory endpoints include pharmacokinetic parameters, hormonal biomarkers, bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain, quality-of-life assessments and exploratory genomic analyses.
The Company intends to explore whether integration of these clinical, pharmacodynamic and genomic data can identify candidate treatment-response biomarkers associated with controlled estradiol suppression, clinically meaningful benefit and treatment tolerability. Any candidate biomarker or multi-gene treatment-response signature identified through PRECISION-E2 would require confirmation in subsequent clinical studies before being used to guide patient selection.
Why PRECISION-E2 Is Different
Unlike conventional endometriosis clinical studies that primarily evaluate safety and efficacy, PRECISION-E2 has been specifically designed to prospectively integrate genomic information with endocrine pharmacology, pharmacokinetics, biomarkers, safety assessments and patient-reported outcomes to better understand why individual women respond differently to hormonal therapy.
The Company believes PRECISION-E2 represents a new generation of endometriosis clinical research by prospectively integrating genomic and biological data into therapeutic development from the outset.
The study has been designed to integrate:
- Whole-genome information from participating women, subject to applicable approvals and governance requirements.
- Hormonal pharmacodynamics, including estradiol, luteinizing hormone and follicle-stimulating hormone.
- Pharmacokinetic exposure.
- Bone turnover biomarkers.
- Clinical symptom improvement.
- Patient-reported quality-of-life outcomes.
- Safety and tolerability; and
- Exploratory analyses of predefined genes and biological pathways associated with estrogen receptor signaling, estrogen synthesis and metabolism, gonadotropin signaling, endometriosis biology, inflammatory pathways and pain perception, including candidate genes such as ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR.
The Company believes this integrated approach has the potential to generate one of the most comprehensive precision medicine datasets assembled in endometriosis and to establish an important scientific foundation for future biomarker-informed development of Teverelix®.
Addressing a Significant Unmet Women's Health Need
Endometriosis is a chronic estrogen-dependent inflammatory disease affecting approximately one in ten women of reproductive age worldwide.
Beyond chronic pelvic pain, dysmenorrhea and infertility, the disease frequently affects education, employment, family planning, emotional wellbeing and long-term quality of life.
Despite multiple available therapies, many women continue to experience inadequate symptom control, treatment-limiting adverse effects, recurrence following treatment discontinuation and variability in therapeutic response.
PRECISION-E2 has been designed to evaluate whether Teverelix® can achieve rapid, controlled and sustained estradiol suppression while minimizing unwanted hypoestrogenic effects and simultaneously generating the pharmacodynamic, clinical and genomic data necessary to optimize dose selection, route of administration and future precision medicine strategies.
About Teverelix®
Teverelix® is a next-generation, long-acting gonadotropin-releasing hormone antagonist being developed by Medicus Pharma through its subsidiary, Antev Ltd.
Teverelix® is designed to produce rapid and reversible suppression of reproductive hormones without the initial hormonal flare associated with GnRH agonists. Its injectable depot formulation is intended to provide sustained exposure and may support less-frequent dosing than currently available daily oral GnRH antagonists.
Teverelix® is being developed across several indications, including advanced prostate cancer in patients with elevated cardiovascular risk, recurrence of acute urinary retention associated with benign prostatic hyperplasia, and women’s health conditions including endometriosis.
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.
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.
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, 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 Company’s expectations regarding the Phase 2 study, the timing and results thereof, including the number patients to be enrolled therein; the Company’s expectations regarding the generation of an early pharmacodynamic signal, decision-grade clinical evidence and a comprehensive Phase 2 dataset for Teverelix®, and the potential to accelerate clinical development, optimize capital allocation and support dose optimization and route selection; the potential for Teverelix® to establish a new treatment paradigm for recurrent AUR; the Company’s expectations regarding the PRECISION-E2 study, including receipt of site-specific Institutional Review Board, ethics committee and any other required regulatory approvals, the timing of study initiation, enrollment and completion, the availability of and access to genomic data and health data infrastructure in the United Arab Emirates, and the potential identification and subsequent validation of candidate treatment-response biomarkers; and potential strategic partnering opportunities 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.
