Medicus Pharma Submits Optimized Phase 2 Study Protocol to U.S. FDA for Teverelix in Acute Urinary Retention
Rhea-AI Summary
Medicus Pharma (NASDAQ: MDCX) submitted an optimized Phase 2 protocol to the U.S. FDA for Teverelix to prevent recurrent acute urinary retention (AURr) in men with BPH. The design targets ~126 patients across the U.S. and Europe, a mechanism-driven primary endpoint of percent change in total prostate volume at Week 12, a single-dose, four-arm randomized design, and an interim analysis after ~50% of patients complete Week 12 to inform dose and route selection.
The study duration is 52 weeks (28-week treatment, 24-week follow-up), and the company cites an approx. $2 billion addressable AURr market.
Positive
- Targeted sample size of ~126 patients (reduces study size ~3-fold)
- Primary endpoint: TPV percent change at Week 12 for early PD signal
- Planned interim analysis at ~50% to inform dose and route selection
- Single-dose, four-arm randomized design enables dose and route differentiation
Negative
- Study uses a single-dose regimen, limiting repeated-dose long-term efficacy data
- Endpoints like AURr events may be underpowered with ~126 patients for clinical outcomes
News Market Reaction – MDCX
On the day this news was published, MDCX gained 9.82%, reflecting a notable positive market reaction. Argus tracked a peak move of +21.2% during that session. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $20.26M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner flags a broader move: 3 peers in focus, with 2 down (e.g., SCYX -4.21%, GELS -5.45%) and 1 up (TLPH +7.42%). Sector summary notes median move around -4.8%, suggesting sector-wide dynamics alongside MDCX’s stock-specific clinical update.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 01 | SkinJect data clarification | Positive | -8.5% | Clarified Phase 2 SkinJect dataset and focus on active treatment arms. |
| Mar 30 | KOL data validation | Positive | -9.6% | Independent KOL validation of SkinJect Phase 2 data and dose selection. |
| Mar 18 | Fireside chat preview | Positive | +0.4% | Announcement of fireside chat to review positive SkinJect topline data. |
| Mar 16 | KOL webcast announcement | Positive | -1.3% | Planned webcast interpreting positive Phase 2 SkinJect topline results. |
| Mar 09 | Topline Phase 2 data | Positive | +34.3% | Reported positive SKNJCT-003 topline results and regulatory/partnering plans. |
Recent clinical-trial headlines have mostly been positive in content but often met with mixed or negative next-day price reactions, showing a tendency toward divergence between upbeat data and short-term trading.
Over the last month, Medicus has repeatedly highlighted positive Phase 2 SkinJect data, including 73% clinical clearance and 40% histological clearance in the 200-µg cohort, plus KOL validation and plans for End-of-Phase 2 FDA discussions. Market reactions to these clinical updates have been volatile, with both sharp gains (up to 34.26%) and notable pullbacks (down to -9.64%). Today’s Teverelix Phase 2 protocol submission extends this clinical narrative beyond SkinJect into AURr and prostate indications.
Historical Comparison
In the past 5 clinical-trial headlines, MDCX moved an average of 3.05%. Today’s 6.43% move on a new Teverelix Phase 2 protocol sits above that typical reaction but remains within the historical volatility range.
Clinical news flow has centered on SkinJect Phase 2 data and interpretive KOL events. This Teverelix Phase 2 AURr protocol advances the broader pipeline from SkinJect-focused updates toward parallel development in urologic indications.
Market Pulse Summary
The stock moved +9.8% in the session following this news. A strong positive reaction aligns with the company’s pattern of sharp moves around clinical milestones. The Teverelix Phase 2 AURr protocol targets a $2 billion market and aims for decision-grade data by Week 12. However, shares trade 95% below the 52-week high and below the $1.93 200-day MA, so prior volatility on clinical news suggests that follow-through has historically been inconsistent.
Key Terms
gnrh antagonist medical
acute urinary retention medical
benign prostatic hyperplasia medical
investigational new drug regulatory
pharmacodynamic medical
randomized, double-blind medical
expanded access ind regulatory
form 10-k regulatory
AI-generated analysis. Not financial advice.
Mechanism-Driven Study Design Focused on Capital Efficiency and Accelerated Development for Near-Term Value Creation, Addressing a
PHILADELPHIA, April 06, 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 therapeutics assets, today announced the Company has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration (“FDA”) for Teverelix, its investigational GnRH antagonist, for the prevention of recurrent acute urinary retention (“AURr”) in men with benign prostatic hyperplasia (“BPH”) as part of its existing open Investigational New Drug (“IND”) for Teverelix.
The Phase 2 study design has been refined under the leadership of Steven A. Kaplan, MD, FACS, a globally recognized leader in urology and men’s health, who will serve as Principal Investigator.
Dr. Kaplan is Professor of Urology at the Icahn School of Medicine at Mount Sinai and has held senior academic appointments at Columbia University and Weill Cornell Medical College, where he served as Vice Chairman of Urology. He is internationally regarded as a leading authority in BPH, lower urinary tract symptoms (“LUTS”) and voiding dysfunction. He has also authored over 1,000 scientific publications, including more than 600 peer-reviewed articles, and is the recipient of the John K. Lattimer Award for Lifetime Achievement in Urology.
“This refined study design reflects a more capital-efficient development strategy intended to accelerate Teverelix’s path to commercialization,” said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. “By focusing on clear pharmacodynamic endpoints and incorporating an interim analysis designed to inform subsequent clinical development, we believe Teverelix can generate actionable clinical data more rapidly, enabling earlier strategic engagement and potential partnering opportunities.”
There are currently no approved pharmacologic therapies specifically indicated to prevent recurrence of AUR, primarily due to enlarged prostate. The Company’s proof-of-concept study design to evaluate Teverelix in AURr represents a novel approach addressing an underserved clinical need, representing an approximately
The updated Phase 2 study design (ANT-2111-02) incorporates:
- A targeted sample size of approximately 126 patients across the United States and Europe
- A design focused on detecting a clear pharmacodynamic signal (total prostate volume reduction)
- A structure optimized for dose and route differentiation
This design demonstrates a data-driven evolution toward generating decision-grade clinical evidence representing an approximately three-fold reduction in study size compared to the original design and a meaningful reduction in overall development cost, with corresponding improvements in development efficiency and execution speed, supporting earlier strategic engagement and partnering discussions. The study is designed to generate an early pharmacodynamic signal within approximately 12 weeks.
AURr Study Design and Endpoints Overview
The optimized Phase 2 study is a randomized, double-blind, single-dose, four-arm design. Patients will be randomized to receive:
- Teverelix 90 mg (intramuscular)
- Teverelix 120 mg (subcutaneous)
- Matched placebo controls
All patients will receive a single injection on Day 1. The duration of the study is 52 weeks, which includes a 28-week treatment period and a 24-week follow-up. The patients will remain on standard-of-care alpha-blocker therapy.
The study is anchored by a mechanism-driven primary endpoint of percent change in total prostate volume (“TPV”) at Week 12. The secondary endpoints include maximum urine flow rate (“Qmax”), post void residual volume (“PVR”), AURr and need for intervention.
An interim analysis will be conducted after approximately 50 percent of patients have completed the Week 12 assessment to inform dose selection, route optimization and future Phase 3 study design. This interim analysis is expected to provide an early pharmacodynamic signal and support timely development decision.
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 therapeutics assets. The Company is actively engaged in multiple countries across three continents.
Company’s key therapeutics 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, collectively representing a ~
Teverelix®, a next generation GnRH antagonist is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing a ~
The Company is actively engaged in following collaborations:
Skinject™ Platform Expansion
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (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, and there can be no assurance that such definitive agreements will be executed.
The Company is exploring co-development of thermostable infectious disease vaccines combining HelixNano’s proprietary mRNA technology with the Medicus microneedle array delivery platform.
Patient Access and Advocacy
In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.
In collaboration with the Gorlin Syndrome Alliance, Medicus is pursuing an Expanded Access IND program to provide Gorlin Syndrome patients with multiple or inoperable BCCs access to SkinJect™, the Company’s investigational D-MNAs, under physician supervision.
AI Enabled Clinical Development
In December 2025, the Company signed a non-binding letter of intent to collaborate with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to develop an AI-driven clinical data analytics platform to support capital-efficient and time-efficient clinical development through data-driven dynamic clinical-site selection, pharmacodynamic (PD) informed patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support the upcoming Teverelix clinical study planned for 2026. There can be no assurance that a definitive agreement will be executed or that the proposed collaboration will proceed as contemplated.
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 Company’s ability to continue as a going concern, statements regarding the Company’s leadership and prospects, 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, high CV risk prostate cancer, women’s health indications like endometriosis, 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 Company’s expectations regarding reported efficacy findings, the overall response rate and potential changes thereto, and whether there will be material changes to its reported SKNJCT-003 topline results and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, 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, 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.
