Medicus Pharma Announces SkinJect® Phase 2 Principal Investigator and Key Opinion Leader (KOL), Babar K. Rao MD, FAAD, to Provide Clinical Interpretation of Positive Data During Business Update Webcast on March 26
Rhea-AI Summary
Medicus Pharma (NASDAQ: MDCX) announced that Dr. Babar K. Rao will provide clinical interpretation of positive Phase 2 SkinJect (SKNJCT-003) topline data during a business webcast on March 26, 2026. The randomized, double-blind study showed 73% clinical clearance in the 200-µg D-MNA arm vs 38% in the device-only arm at Day 57, with 40% histological clearance in the active cohort. Management views the dataset as decision-grade evidence to pursue regulatory discussions and potential strategic partnerships.
Positive
- 73% clinical clearance in 200-µg D-MNA arm at Day 57
- Randomized, double-blind three-arm design with device-only control
- 40% histological clearance in active 200-µg cohort supports drug effect
- Company views data as decision-grade evidence for regulatory talks and partnerships
Negative
- 38% clinical clearance in device-only arm suggests substantial mechanical/immune effect
- 40% histological clearance lags clinical clearance, leaving tissue-confirmation uncertainty at Day 57
- Key collaborations (MoU, LOI) are non-binding and not guaranteed
News Market Reaction – MDCX
In the Mar 16 session, MDCX declined 4.01%, reflecting a moderate negative market reaction. Argus tracked a trough of -16.7% from its starting point during tracking. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 09 | Phase 2 data readout | Positive | +34.3% | Detailed positive SKNJCT-003 Phase 2 results and partnering/FDA meeting plans. |
| Mar 05 | Topline data release | Positive | -50.9% | Initial SKNJCT-003 topline showing 73% clinical and 40% histologic clearance at Day 57. |
| Jan 05 | Conference preview | Positive | +0.0% | Biotech Showcase presentation preview with Phase 2 catalysts and regulatory strategy for SkinJect. |
| Dec 15 | Enrollment completion | Positive | -3.2% | Completion of 90-patient enrollment for SKNJCT-003 and multiple supporting regulatory milestones. |
| Nov 13 | UK trial approvals | Positive | -5.4% | Full UK regulatory and ethics approvals to expand SKNJCT-003 and prior clearance data. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial headlines have often seen weak or negative follow-through, with only one of five same-tag events showing a strongly positive next-day move.
Over the past months, Medicus has steadily advanced SkinJect’s Phase 2 program, moving from UK approvals and full enrollment in SKNJCT-003 to completed topline data showing 73% clinical and 40% histological clearance in the 200-µg cohort. Prior updates framed the dataset as decision-grade for FDA interactions and partnering. Today’s news builds on that arc by emphasizing investigator-led clinical interpretation, reinforcing earlier efficacy signals rather than introducing new topline figures.
Key Terms
phase 2 medical
randomized, double-blind medical
doxorubicin medical
microneedle medical
basal cell carcinoma medical
histological clearance medical
expanded access ind regulatory
gnrh antagonist medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Phase 2 Study Demonstrated
PHILADELPHIA, March 16, 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 that Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company’s leadership team during a business update webcast on March 26, 2026 at 11:30 a.m. Eastern time.
The SKNJCT-003 study represents a randomized, double-blind Phase 2 clinical trial designed to rigorously evaluate the therapeutic contribution of doxorubicin delivered through the SkinJect® microneedle platform in patients with nodular basal cell carcinoma.
The update call will follow the filing of the Company’s Form 10-K for fiscal year 2025, expected after market close on March 25, 2026.
During the call, Dr. Rao will provide clinical interpretation and independent investigator perspective on the recently reported positive dataset from SKNJCT-003.
Basal cell carcinoma (BCC), a highly immunogenic tumor, is the most common cancer worldwide, and SkinJect is designed to provide a minimally invasive treatment option that could potentially reduce the need for surgical excision. The
Dr. Rao is widely recognized as a leading academic dermatologist, dermatopathologist, and clinical investigator in skin oncology.
He currently serves as:
- Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
- Clinical Associate Professor of Dermatology, Weill Cornell Medical College
- Adjunct Professor of Dermatology, California Health Sciences University
Dr. Rao is a board-certified dermatologist and Fellow of the American Academy of Dermatology (FAAD) with decades of experience in dermatologic oncology, dermatopathology, and clinical research.
He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at internationally recognized institutions including, New York University Medical Center, Boston University School of Medicine, University of Texas Southwestern Medical Center and St. John’s Institute of Dermatology, University of London.
Dr. Rao has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in multiple dermatology clinical trials evaluating novel treatments for skin cancer and other dermatologic diseases.
Dr. Rao serves as Principal Investigator of the SKNJCT-003 clinical trial, titled:
“A randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma.”
The randomized design of SKNJCT-003, including a device-only control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system.
The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (
The biological activity observed in the device-only arm likely reflects tumor disruption and localized immune activation resulting from microneedle insertion, a phenomenon previously described in intratumoral and microneedle-mediated device studies evaluating solid tumors.
The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving
Importantly, the magnitude of response observed in the active treatment cohort relative to the device-only control arm provides clinically meaningful evidence of drug-mediated therapeutic effect within a biologically active microneedle delivery platform.
The Company believes the dataset represents decision-grade evidence supporting continued development of the SkinJect program and advancement toward regulatory discussions and potential strategic partnerships.
Corporate Update Call Details
| Event: | Medicus Pharma Business Update Conference Call |
| Date: | Thursday, March 26, 2026 |
| Time: | 11:30 a.m. Eastern Time |
| Pre-registration: | https://dpregister.com/sreg/10207261/10379bd1029 |
| Dial-in (U.S./Canada) | 833-890-6070 |
| Dial-in (international) | 412-504-9736 |
| Webcast: | https://event.choruscall.com/mediaframe/webcast.html?webcastid=DeCGoBHR |
Participants will include:
- Dr. Raza Bokhari — CEO & Executive Chairman, Medicus Pharma
- Carolyn Bonner---President & CFO. Medicus Pharma
- Dr. Babar K. Rao — Principal Investigator, SKNJCT-003
- Members of the Medicus executive leadership team
Topics will include:
- Financial performance of the company and overview of the business outlook
- Clinical interpretation of the SkinJect Phase 2 topline dataset
- Investigator perspective on study endpoints and tumor response mechanisms
- Development and partnership outlook for the SkinJect program
- Development and partnership outlook for the Teverelix Program
Participants are encouraged to pre-register for the conference call using this link to receive a dial-in number and PIN to bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-890-6070 (U.S./Canada) or 412-504-9736 (international). A webcast of the call can be accessed here.
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 an ~
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 an ~
The Company 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 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 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, 2024 (the "Annual Report"), 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.
