MDCX
**** Disseminated on Behalf of Medicus Pharma
Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention
MDCX's pro forma cash position is approximately $30 million providing a runway of more than twenty-four (24) months after Non Dilutive Funding
The FDA issued a "study may proceed" clearance for MDCX's Phase 2b Teverelix study in advanced prostate cancer, officially opening the door for the company's next major clinical milestone
Read the Investor Presentation HERE
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Hello Everyone,
In a period where medical innovation is increasingly driven by urgent patient needs, one emerging biotech company is positioning itself to make a meaningful impact in dermatologic oncology.
MDCX is checking a lot of boxes right now. FDA clearance? Check. Multiple Phase 2 programs? Check. Potential first-in-class opportunity? Check. Partnership potential? Absolutely.
The biotech space loves companies that combine fresh regulatory momentum with upcoming catalysts, and that's exactly the lane MDCX is driving in right now.
Medicus Pharma is advancing breakthrough non-invasive skin cancer treatment through its SkinJect subsidiary, with positive Phase 2 topline data positioning the company for FDA end-of-phase 2 meetings and strategic partnerships. Combined with a second therapeutic program in prostate cancer and analyst targets suggesting upside potential, MDCX represents a biotech story with multiple near-term catalysts.
The global market for skin cancer treatments, valued at $10.87 billion in 2024, is projected to expand to $19.27 billion by 2032, reflecting a steady 7.42% compound annual growth rate. Within this expanding landscape, a focused team is advancing a promising therapy aimed at improving both patient experience and clinical outcomes.
The underlying science is ambitious, and its potential implications are drawing growing attention across the medical community.
Just a few sessions back the company made some noise after they dropped news stating that they had received positive written feedback from the FDA and central IRB approval, with minor modifications, for a redesigned Phase 2 study of Teverelix, its long-acting GnRH antagonist being developed for men who've had a first episode of acute urinary retention (AUR) linked to benign prostatic hyperplasia. The redesigned trial, ANT-2111-02, will enroll approximately 126 patients across the U.S. and Europe, down from about 390 in the company's original plan, while still aiming to generate solid enough data to guide dosing, delivery method, and future development. CEO Raza Bokhari framed the redesign as a major efficiency gain, cutting enrollment by roughly two-thirds without sacrificing the ability to produce meaningful clinical evidence.
With the FDA granting a "may proceed" green light for MDCX's Phase 2b Teverelix trial targeting advanced prostate cancer, the company is formally clearing the path toward the company's next big clinical checkpoint.
That's more than a routine box-check—it's a substantial validation event that shifts the narrative from possibility to actual execution.
In the biotech world, regulatory momentum can be a serious eye-catcher, and MDCX just racked up a significant one. The company is now advancing toward producing the kind of dataset that could shape future regulatory conversations and potentially draw interest from larger pharmaceutical players scouting promising late-stage prospects.
Here's where it gets compelling.
Teverelix isn't aiming to be just another me-too prostate cancer drug. It's engineered as a next-generation, long-acting GnRH antagonist that may produce fast testosterone suppression while avoiding the flare reaction commonly tied to older therapies.
It was designed to tackle a genuine clinical challenge more intelligently.
And the picture expands further when factoring in cardiovascular risk. A large share of prostate cancer patients also contend with heart-related conditions, and fresh data on GnRH antagonists has sparked considerable curiosity thanks to their possible cardiovascular advantages over legacy treatment options.
Should Teverelix keep living up to its potential, MDCX could end up holding a possible first-in-class asset aimed at an enormous patient base. That's the kind of narrative capable of drawing rapid attention across the biotech landscape.
MDCX isn't attempting to construct a massive commercial team and go it alone. The approach is straightforward: push forward promising assets, produce meaningful Phase 2 results, and set those programs up for potential collaborations, licensing arrangements, or other value-generating outcomes.
Major pharmaceutical companies are perpetually hunting for innovative assets to bolster their pipelines, and encouraging Teverelix results could make MDCX progressively harder to overlook. The company is already building the foundation—advancing its clinical work, reinforcing operations, and positioning the asset for upcoming discussions.
While Teverelix soaks up much of the attention, SkinJect could be one of the most overlooked components of the MDCX story.
The company's dissolvable microneedle platform for non-melanoma skin cancer recently delivered promising Phase 2 findings showing a distinct dose-response pattern, with more robust results in the higher-dose arm. Better still, the safety data remained clean, with zero treatment-related serious adverse events recorded.
In other words, MDCX isn't a single-asset company.
Rather, it has several clinical programs progressing simultaneously, opening up multiple chances for value-generating news throughout the year.
MDCX announced encouraging fresh Phase 2 data from its SKNJCT-003 trial assessing its Doxorubicin Microneedle Array (D-MNA) for nodular basal cell carcinoma (BCC).
The expanded review of 69 eligible patients revealed a clear dose-response trend, with the top-dose 200-microgram cohort delivering the best results.
By Day 57, the high-dose group reached 64% clinical clearance and 55% histological clearance, substantially exceeding both the lower-dose arm and the device-only control group.
Notably, the therapy was well-tolerated, with no treatment-related serious adverse events or systemic toxicity reported.
Leadership believes this data reinforces the program's regulatory footing, supports upcoming FDA dialogue, and may pave a clearer route toward late-stage development as SkinJect continues advancing as a potential new option for treating basal cell carcinoma!
Portfolio Companies
SkinJectA: Novel non-invasive regimen to treat skin cancer; especially Basal Cell Carcinoma Micro needle Array DesignThe D-MNA consists of a 15 × 15 mm array with a 13× 13 mm “live” area of micro needles. Each needle is750 microns long, with doxorubicin hydrochlorid concentrated in the upper two-thirds.
Mechanism of Action: Doxorubicin’s MoA is believed to act via DNA intercalation, with evidence suggesting preservation of tumor antigenicity during cell death — an immunogenic “good death” for tumor cells.
Dissolvable Delivery: Manufactured from carboxymethyl cellulose (CMC),which readily dissolves in the skin. These needles penetrate the stratum corneum and create microchannels through which therapeutic agents may be delivered.
In-Clinic Administration: Administered in-clinic immediately upon diagnosis by any dermatologist. One topical application per week during a 30-minute office visit over threeweeks — effective during the surgical lead time (2–8months).
Teverelix trifluoroacetate (Teverelix TFA)
Teverelix is a gonadotrophin-releasing hormone (GnRH) antagonist with a novel formulation. GnRH antagonists rapidly suppress the effects of sex hormones by limiting their production. This is therapeutically valuable for conditions that are controlled by sex hormone secretion, including prostate cancer, benign prostatic hyperplasia, and endometriosis. Recent data suggest that GnRH antagonists may have multiple therapeutic advantages over the traditionally used GnRH agonists, and therefore have the potential to supersede GnRH agonists as the gold-standard treatment.
GnRH agonists and antagonists are similar in that they both bind to the same therapeutic target, the GnRH receptor in the pituitary gland. However, they have distinct mechanisms of action.
NEWS
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Medicus Pharma Advances SkinJect® into Registrational Development for Gorlin Syndrome
Jun 3, 2026
MANAGEMENT
Raza Bokhari, MD
Executive Chairman & CEO
A recipient of Philadelphia Business Journal’s "40 under 40" award, Dr. Raza Bokhari – a physician turned serial entrepreneur - has a demonstrated successful track record in aggregating and accelerating life sciences, healthcare services and Pharmaceutical R&D companies.He previously served as Executive Chairman and CEO of FSD Pharma (Nasdaq: HUGE), where his strategies successfully pivoted the company out of medicinal cannabis and into a clinical stage pharmaceutical R&D, a transition marked by a NASDAQ listing in January 2020, and raising nearly $100M institutional capital to fuel growth and expansion.Dr. Bokhari has a Doctor of Medicine degree from the University of Punjab, Rawalpindi Medical College, and an Executive MBA from Temple University, Fox School of Business & Management.In addition to his corporate roles, Dr. Bokhari serves as the Vice Chairman of the World Affairs Council of Philadelphia. He formerly served on the Board of Temple University’s Fox School of Business and Management as Chairman of the Executive Advisory Committee and was a Trustee of the esteemed Franklin Institute and Foreign Policy Research Institute.Dr. Bokhari, through his family foundation, believes in giving back and investing in the community. In recognition of a $1 million gift, he made to his alma mater, Temple University, its Fox Business School named the Innovation & Entrepreneurship Institute Suite in his honor. The school acknowledged Dr. Bokhari in 2018 by naming him a Centennial Honoree, a special collection of entrepreneurs, visionaries, and disruptors who helped shape the Fox School and the business world since 1918. More information on Dr. Bokhari, is available at www.Razabokhari.com
Robert J. Ciaruffoli
Lead Director
Robert J. Ciaruffoli is a Certified Public Accountant and Co-Founder of the Philadelphia angel investor network Broad Street Angels. He previously served as Chairman and CEO of the accounting and advisory firm ParenteBeard/Baker Tilly. Under his leadership, the firm expanded from a regional Pennsylvania practice into a national firm. Mr. Ciaruffoli has served on numerous corporate boards. He holds a Bachelor of Science in Accounting from Kings College and served in the U.S. Marine Corps.
Hon. Cathy McMorris Rodgers
Director
The Honorable Cathy McMorris Rodgers is a trailblazer and dedicated public servant who has spent three decades serving her state and country. She served as the U.S. Representative for Washington's 5th Congressional District from 2004 to 2025. As a high-profile congressional leader, innovative policymaker, and trust-builder, she is regarded as a unifying force and a high-impact leader with a long history of accomplishments. Cathy is people-centric, guided by values, and motivated by a mission.
In 1994, Cathy was appointed to the Washington State House of Representatives; in 2002, her colleagues elected her Republican Leader, the first female House Leader in Washington State. Cathy was elected to Congress in 2004.
In the U.S. Congress, Cathy quickly rose to leadership: in her freshman class, as Conference Vice Chair, and later as Republican Conference Chair, one of the top four House leadership positions. In 2021, she assumed Republican Leadership of the powerful Energy and Commerce Committee (E&C) and Chairmanship of the E&C Committee after the 2022 election. She is the first female Chair since the E&C Committee's founding in 1795.
Gaining national attention in 2014, Cathy authored and delivered the Republican response to President Obama's 2014 State of the Union Address. Cathy frequently appears on major media networks, including Meet the Press, Fox News Sunday, Special Report with Brett Baier, The Lead with Jake Tapper, and ABC Evening News.
Larry Kaiser, MD, FACS
Director
Dr. Larry Kaiser is Managing Director of the Healthcare Industry Group at Alvarez and Marsal. He previously served as President and CEO of the Temple University Health System, Dean of Temple University's Lewis Katz School of Medicine, and Senior Executive Vice President for Health Sciences at Temple University. Dr. Kaiser helped acquire and develop many programs at Temple, including the number one lung transplant program in the U.S. Dr. Kaiser graduated from the Tulane University School of Medicine in 1977. He completed his general surgery residency and a surgical oncology fellowship at UCLA. He also completed a residency in cardiovascular and thoracic surgery at the University of Toronto. Before joining the University of Pennsylvania, Dr. Kaiser held positions at Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, and Washington University School of Medicine.
Sincerely,
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