The FDA has cleared Medicus Pharma's (NASDAQ: MDCX) IND for a Phase 2b registrational study evaluating SkinJect® for patients with Gorlin syndrome, marking an important step toward developing the first FDA-approved non-invasive treatment option for this rare genetic condition. In a recent Proactive Investors interview, Executive Chairman and CEO Dr. Raza Bokhari discusses what this milestone means, the planned registrational study and the significant unmet need facing patients who often undergo repeated surgeries throughout their lives. Watch the interview: https://lnkd.in/gH6fKsNZ Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Viktoriia Slepeniuk Amanda Napier Madison Weisz Manas Narula Gabrielle Petro
Medicus Pharma Ltd.
Biotechnology Research
Medicus Pharma Ltd. (NASDAQ: MDCX) is focused on accelerating clinical development programs of novel therapeutic assets
About us
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 designed to transform the standard of care. The company is actively engaged in multiple countries spread over three continents. Our strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies that are best positioned to conduct late-stage development and commercialization. Our Phase 2 studies are designed to generate decision-grade clinical, regulatory and operational data packages intended to support partnering discussions and potential licensing transactions. We look into opportunities where an unmet need exists for improved patient safety and efficacy. The Company is currently advancing the clinical development program of its novel Doxorubicin containing Microneedle Array (D-MNA) treatment to non-invasively treat basal cell carcinoma of the skin (BCC). Medicus is also developing Teverelix, a next generation GnRH Antagonist as a first in class market product for Acute Urinary Retention (AURr) and high CV risk Prostate Cancer. D-MNA and Teverelix, collectively represent ~$8 billion in potential market opportunity.
- Website
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www.medicuspharma.com
External link for Medicus Pharma Ltd.
- Industry
- Biotechnology Research
- Company size
- 11-50 employees
- Type
- Public Company
- Founded
- 2023
- Specialties
- Pharma R&D
Employees at Medicus Pharma Ltd.
Updates
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The U.S. FDA has issued a “Study May Proceed” letter authorizing the initiation of Medicus Pharma's (NASDAQ: MDCX) NDA-enabling registrational Phase 2b study evaluating SkinJect® in patients with Gorlin Syndrome. The study incorporates FDA recommendations designed to strengthen the protocol, including combined clinical and histological clearance endpoints, extended patient follow-up and additional measures to further enhance the scientific rigor of the trial. This authorization represents an important step in advancing the SkinJect® program as we work to develop a potential new treatment option for patients with Gorlin Syndrome, a rare genetic disorder that can result in the lifelong development of multiple basal cell carcinomas requiring repeated surgeries. Read the full announcement: https://lnkd.in/gVVzG8wc Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Viktoriia Slepeniuk Manas Narula Madison Weisz Gabrielle Petro Amanda Napier
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Medicus Pharma (NASDAQ: MDCX) has received written FDA feedback and central Institutional Review Board approval, with modifications, for its optimized Phase 2 study of Teverelix in men following a first episode of acute urinary retention. The redesigned study, ANT-2111-02, is now expected to enroll ~126 patients, compared with ~390 under Medicus's previously disclosed development plan. Medicus believes this reflects a more efficient trial design and that the FDA's comments are operational in nature, requiring no changes to the study's scientific rationale, patient population, treatment arms, primary endpoint, or planned interim analysis. Read the full announcement: https://lnkd.in/gKAZsk9W Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Viktoriia Slepeniuk Manas Narula Madison Weisz Gabrielle Petro
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Medicus Pharma ($MDCX) is heading to BIO 2026 in San Diego this week. CMO Dr. Faisal Mehmud will share the latest on SkinJect — the registrational strategy for Gorlin Syndrome and the planned End-of-Phase 2 meeting — plus updates on Teverelix, including the newly launched PRECISION-E2 Phase 2a endometriosis study. Wednesday, June 24 | 3:00 PM PT | Theater 2 Read the full announcement: https://lnkd.in/gD2g5x_t Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Viktoriia Slepeniuk Amanda Napier Manas Narula Madison Weisz Gabrielle Petro
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This just in: Medicus Pharma (NASDAQ: MDCX) CEO and Executive Chairman Dr. Raza Bokhari sat down with Dermatology Times to discuss SkinJect and the results from our Phase 2 proof-of-concept study. The 90-patient, triple-arm study conducted across nine U.S. sites demonstrated a clean dose response. In the 200 microgram cohort evaluated at day 57, SkinJect achieved 64% clinical clearance and 55% histological clearance. Dr. Bokhari also spoke about our collaboration with the Gorlin Syndrome Alliance and our newly submitted IND to study SkinJect for the thousands of people across the U.S. living with Gorlin syndrome — a rare genetic condition characterized by recurring basal cell lesions over a lifetime — who, to this day, have no FDA-approved first-line therapy. Watch the full interview here: https://lnkd.in/e2CMe98K Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna Viktoriia Slepeniuk Manas Narula Madison Weisz Gabrielle Petro
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Medicus Pharma (NASDAQ: MDCX) has submitted a Rare Pediatric Disease Designation request to the FDA for SkinJect in Gorlin Syndrome, a rare genetic disorder in which patients face a lifetime of recurring surgeries and progressive treatment burden beginning at a young age. If granted, SkinJect may become eligible for a Priority Review Voucher, potentially reducing FDA review time for a future New Drug Application from approximately ten months to six months. The submission follows the Company's previously announced Orphan Drug Designation application and registrational study design (SKNJCT-005), currently under FDA review. Read the full announcement: https://lnkd.in/eV4C5MCV Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Viktoriia Slepeniuk Manas Narula Madison Weisz
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New in Discover Pharma: Medicus Pharma filed an IND for PRECISION-E2, a genomics-enabled Phase 2a study evaluating Teverelix in endometriosis. The trial integrates with the Emirati Genome Program to advance personalized care for women's health. Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Ed Brennan Anna K. Baran-Djokovic Viktoriia Slepeniuk Amanda Napier Manas Narula Madison Weisz Gabrielle Petro Full story: https://lnkd.in/eUwJHZ6a
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Endometriosis affects approximately one in ten women of reproductive age worldwide. Despite multiple approved therapies, many women continue to experience inadequate symptom control, side effects and symptom recurrence. For too long, treatment has followed a one-size-fits-all approach. Medicus Pharma (NASDAQ: MDCX) is working to change that. Today, the company announced the submission of an IND application to the Department of Health, Abu Dhabi for PRECISION-E2, a first-of-its-kind Phase 2a genomics-enabled clinical trial evaluating Teverelix® in women with symptomatic endometriosis in the UAE. The study will enroll participants from the Emirati Genome Program, one of the world's largest national genomics initiatives, to explore how genetic variation may influence response to hormonal therapy. Read the full announcement: https://lnkd.in/eZtyVTdA Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Anna K. Baran-Djokovic Ed Brennan Viktoriia Slepeniuk Amanda Napier Manas Narula Madison Weisz Gabrielle Petro
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At the Market Movers Investor Summit, Medicus Pharma (NASDAQ: MDCX) CEO and Executive Chairman Dr. Raza Bokhari participated in The Money Channel's CEO Sessions to discuss our strategy in progressing our clinical pipeline. Medicus focuses on advancing promising novel therapies through Phase 2 proof-of-concept, and then pursuing licensing or strategic partnerships with larger industry players to conduct late-stage development and commercialization. Dr. Bokhari also spoke to how Medicus is incorporating AI and machine learning into its clinical development process, with a focus on making trials more time and capital-efficient. Watch the full interview: https://lnkd.in/eBaYYd2A Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Ed Brennan Anna K. Baran-Djokovic Viktoriia Slepeniuk Amanda Napier Manas Narula Madison Weisz Gabrielle Petro
Market Movers Investor Summit | CEO Sessions | Dr. Raza Bokhari, CEO - Medicus Pharma
moneychannelnyc.vids.io
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Last month, Medicus Pharma (NASDAQ: MDCX) CEO and Executive Chairman Dr. Raza Bokhari joined The Money Channel's CEO Sessions at the D. Boral Capital Conference 2026 to discuss where SkinJect and the Company’s broader clinical pipeline stand today. Basal Cell Carcinoma is the most common cancer in the world, with millions of new cases diagnosed annually in the U.S. alone. Today, the only proven effective treatment is surgery, which is expensive, painful and limited by the availability of trained surgeons. Millions of patients are left waiting. SkinJect is being developed to change that equation. Watch the full interview: https://lnkd.in/e2rCep6a Raza Bokhari Carolyn Bonner Andrew Smith, Exec MBA Faisal Mehmud Ed Brennan Viktoriia Slepeniuk Anna K. Baran-Djokovic Amanda Napier Manas Narula Madison Weisz Gabrielle Petro
D. Boral Conference 2026 | CEO Sessions | Dr. Raza Bokhari, CEO - Medicus Pharma
moneychannelnyc.vids.io