Medicus Pharma Receives FDA Clearance for Teverelix Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
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Should l Buy MDCX?
Source: Newsfilter
- FDA Approval for Clinical Study: Medicus Pharma has received FDA clearance to initiate a Phase 2b dose-optimization study for Teverelix, enrolling 40 men with advanced prostate cancer suitable for androgen deprivation therapy, indicating strategic progress in the precision medicine sector.
- Study Design Details: The trial will implement a loading dose of 540 mg, followed by 360 mg every six weeks, aiming for over 90% confirmation of medical castration by Day 29, which, if successful, will provide a new treatment option for advanced prostate cancer patients and fill a significant market gap.
- Cardiovascular Safety Focus: Teverelix's mechanism avoids the testosterone surge associated with GnRH agonists, potentially reducing cardiovascular risks, particularly for patients with pre-existing cardiovascular conditions, which is expected to attract a patient demographic with high safety concerns.
- Significant Market Potential: With approximately 300,000 to 500,000 men in the U.S. living with advanced prostate cancer, representing an annual market opportunity exceeding $4 billion, successful clinical trials will lay a foundation for Medicus Pharma's long-term growth and enhance its competitiveness in the biopharmaceutical industry.
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Wall Street analysts forecast MDCX stock price to rise
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Current: 0.993
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Current: 0.993
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About MDCX
Medicus Pharma Ltd. is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets. SkinJect Inc., a wholly owned subsidiary of the Company, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. It is conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. It has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the UAE. Its subsidiary, Antev Limited, is a late clinical stage biotech company, developing Teverelix, a GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse episodes due to enlarged prostate.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Medicus Pharma Receives FDA Clearance for Teverelix Study
- FDA Approval for Clinical Study: Medicus Pharma has received FDA clearance to initiate a Phase 2b dose-optimization study for Teverelix, enrolling 40 men with advanced prostate cancer suitable for androgen deprivation therapy, indicating strategic progress in the precision medicine sector.
- Study Design Details: The trial will implement a loading dose of 540 mg, followed by 360 mg every six weeks, aiming for over 90% confirmation of medical castration by Day 29, which, if successful, will provide a new treatment option for advanced prostate cancer patients and fill a significant market gap.
- Cardiovascular Safety Focus: Teverelix's mechanism avoids the testosterone surge associated with GnRH agonists, potentially reducing cardiovascular risks, particularly for patients with pre-existing cardiovascular conditions, which is expected to attract a patient demographic with high safety concerns.
- Significant Market Potential: With approximately 300,000 to 500,000 men in the U.S. living with advanced prostate cancer, representing an annual market opportunity exceeding $4 billion, successful clinical trials will lay a foundation for Medicus Pharma's long-term growth and enhance its competitiveness in the biopharmaceutical industry.
See More
Medicus Pharma to Ring Nasdaq Opening Bell on January 22, 2026, Celebrating One-Year Anniversary
- Anniversary Celebration: Medicus Pharma will ring the Nasdaq Opening Bell on January 22, 2026, at the Nasdaq MarketSite in Times Square, New York, marking its one-year anniversary as a publicly listed company and highlighting its steady growth in the capital markets.
- Significant Clinical Progress: The company is advancing two key therapeutic assets, SkinJect targeting basal cell carcinoma with an estimated $2 billion market opportunity, and Teverelix for high cardiovascular risk prostate cancer patients, representing a combined market potential of $6 billion, showcasing its strategic positioning in precision medicine.
- Clinical Trial Advancements: Medicus has successfully enrolled 90 patients in the Phase 2 clinical trial for SkinJect in the U.S., with topline results expected in Q1 2026, which will lay the groundwork for future partnership opportunities and enhance the company's influence in the biopharmaceutical sector.
- Strategic Collaboration Expansion: The company has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at improving capital-efficient clinical development, expected to support an upcoming Teverelix clinical study planned for 2026.
See More
Medicus Pharma Rings Nasdaq Opening Bell to Celebrate One-Year Listing Anniversary
- Anniversary Celebration: Medicus Pharma will ring the Nasdaq Opening Bell on January 22, 2026, in Times Square, New York, marking its one-year anniversary as a public company, reflecting its stability and growth potential in the capital markets.
- Clinical Development Progress: The company is focused on advancing key therapeutic assets like SkinJect and Teverelix, with SkinJect targeting a $2 billion market opportunity for basal cell carcinoma and Teverelix addressing high cardiovascular risk in prostate cancer patients, collectively representing a $6 billion commercial value.
- Clinical Trial Results: The Phase 2 trial for SkinJect is nearing completion of patient enrollment, with topline results expected in Q1 2026, potentially creating partnership opportunities and further enhancing the company's influence in the biotech sector.
- Strategic Collaboration and Expansion: The partnership with the Gorlin Syndrome Alliance aims to provide expanded access to SkinJect for patients with multiple basal cell carcinomas, expected to gather crucial safety and tolerability data, thereby strengthening the company's market position in rare diseases.
See More
Medicus Pharma (NASDAQ: MDCX) Announces Teverelix Clinical Data Accepted for AACE 2026 Presentation
- Clinical Data Acceptance: Medicus Pharma's Teverelix clinical data has been accepted for presentation at the AACE 2026 Annual Meeting, marking a significant recognition in the biopharmaceutical field that could enhance investor confidence.
- Significant Trial Results: In two randomized controlled Phase I studies, 48 healthy women receiving Teverelix injections showed rapid suppression of LH and FSH within 24 hours, indicating the drug's potential in women's health, particularly for endometriosis treatment.
- Favorable Safety Profile: The results demonstrated that Teverelix maintained stable bone turnover markers without evidence of short-term bone loss, enhancing its safety for clinical use and potentially attracting more strategic partnerships.
- Strategic Development Focus: Medicus plans to conduct a Phase 2 study of Teverelix in the UAE, aiming to further validate its application in women's health, showcasing the company's emphasis on emerging markets and strategic growth opportunities.
See More
Medicus Pharma Names Carolyn Bonner as CFO and President
Leadership Change: Carolyn Bonner has been appointed as the Chief Financial Officer of Medicus Pharma Ltd. (MDCX) while continuing her role as President, following the resignation of Jim Quinlan due to health issues.
Background of New CFO: Before joining Medicus, Bonner served as the executive chief of PCL, Inc., a specialty laboratory accredited by CAP.
Stock Performance: MDCX shares experienced a 7.31% increase, closing at $2.2 on the Nasdaq.
Disclaimer: The views expressed in the article are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
See More
Medicus Pharma names new Chief Financial Officer
New CFO Appointment: Medicus Pharma (MDCX) has appointed Carolyn Bonner as chief financial officer, effective immediately.
Interim Role: Bonner had been serving as the acting CFO since September 12, 2025, while also holding the position of president.
Resignation of Former CFO: Jim Quinlan, the former CFO and co-founder of the company, has resigned due to health reasons.
Company Financial Updates: Medicus Pharma Ltd. has reported its Q3 results and additional financial information is available through Seeking Alpha’s Quant Rating and historical earnings data.
See More
Medicus Pharma Receives FDA Clearance for Teverelix Study
- FDA Approval for Clinical Study: Medicus Pharma has received FDA clearance to initiate a Phase 2b dose-optimization study for Teverelix, enrolling 40 men with advanced prostate cancer suitable for androgen deprivation therapy, indicating strategic progress in the precision medicine sector.
- Study Design Details: The trial will implement a loading dose of 540 mg, followed by 360 mg every six weeks, aiming for over 90% confirmation of medical castration by Day 29, which, if successful, will provide a new treatment option for advanced prostate cancer patients and fill a significant market gap.
- Cardiovascular Safety Focus: Teverelix's mechanism avoids the testosterone surge associated with GnRH agonists, potentially reducing cardiovascular risks, particularly for patients with pre-existing cardiovascular conditions, which is expected to attract a patient demographic with high safety concerns.
- Significant Market Potential: With approximately 300,000 to 500,000 men in the U.S. living with advanced prostate cancer, representing an annual market opportunity exceeding $4 billion, successful clinical trials will lay a foundation for Medicus Pharma's long-term growth and enhance its competitiveness in the biopharmaceutical industry.
See More
Medicus Pharma to Ring Nasdaq Opening Bell on January 22, 2026, Celebrating One-Year Anniversary
- Anniversary Celebration: Medicus Pharma will ring the Nasdaq Opening Bell on January 22, 2026, at the Nasdaq MarketSite in Times Square, New York, marking its one-year anniversary as a publicly listed company and highlighting its steady growth in the capital markets.
- Significant Clinical Progress: The company is advancing two key therapeutic assets, SkinJect targeting basal cell carcinoma with an estimated $2 billion market opportunity, and Teverelix for high cardiovascular risk prostate cancer patients, representing a combined market potential of $6 billion, showcasing its strategic positioning in precision medicine.
- Clinical Trial Advancements: Medicus has successfully enrolled 90 patients in the Phase 2 clinical trial for SkinJect in the U.S., with topline results expected in Q1 2026, which will lay the groundwork for future partnership opportunities and enhance the company's influence in the biopharmaceutical sector.
- Strategic Collaboration Expansion: The company has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at improving capital-efficient clinical development, expected to support an upcoming Teverelix clinical study planned for 2026.
See More
Medicus Pharma Rings Nasdaq Opening Bell to Celebrate One-Year Listing Anniversary
- Anniversary Celebration: Medicus Pharma will ring the Nasdaq Opening Bell on January 22, 2026, in Times Square, New York, marking its one-year anniversary as a public company, reflecting its stability and growth potential in the capital markets.
- Clinical Development Progress: The company is focused on advancing key therapeutic assets like SkinJect and Teverelix, with SkinJect targeting a $2 billion market opportunity for basal cell carcinoma and Teverelix addressing high cardiovascular risk in prostate cancer patients, collectively representing a $6 billion commercial value.
- Clinical Trial Results: The Phase 2 trial for SkinJect is nearing completion of patient enrollment, with topline results expected in Q1 2026, potentially creating partnership opportunities and further enhancing the company's influence in the biotech sector.
- Strategic Collaboration and Expansion: The partnership with the Gorlin Syndrome Alliance aims to provide expanded access to SkinJect for patients with multiple basal cell carcinomas, expected to gather crucial safety and tolerability data, thereby strengthening the company's market position in rare diseases.
See More
Medicus Pharma (NASDAQ: MDCX) Announces Teverelix Clinical Data Accepted for AACE 2026 Presentation
- Clinical Data Acceptance: Medicus Pharma's Teverelix clinical data has been accepted for presentation at the AACE 2026 Annual Meeting, marking a significant recognition in the biopharmaceutical field that could enhance investor confidence.
- Significant Trial Results: In two randomized controlled Phase I studies, 48 healthy women receiving Teverelix injections showed rapid suppression of LH and FSH within 24 hours, indicating the drug's potential in women's health, particularly for endometriosis treatment.
- Favorable Safety Profile: The results demonstrated that Teverelix maintained stable bone turnover markers without evidence of short-term bone loss, enhancing its safety for clinical use and potentially attracting more strategic partnerships.
- Strategic Development Focus: Medicus plans to conduct a Phase 2 study of Teverelix in the UAE, aiming to further validate its application in women's health, showcasing the company's emphasis on emerging markets and strategic growth opportunities.
See More
Medicus Pharma Names Carolyn Bonner as CFO and President
Leadership Change: Carolyn Bonner has been appointed as the Chief Financial Officer of Medicus Pharma Ltd. (MDCX) while continuing her role as President, following the resignation of Jim Quinlan due to health issues.
Background of New CFO: Before joining Medicus, Bonner served as the executive chief of PCL, Inc., a specialty laboratory accredited by CAP.
Stock Performance: MDCX shares experienced a 7.31% increase, closing at $2.2 on the Nasdaq.
Disclaimer: The views expressed in the article are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
See More
Medicus Pharma names new Chief Financial Officer
New CFO Appointment: Medicus Pharma (MDCX) has appointed Carolyn Bonner as chief financial officer, effective immediately.
Interim Role: Bonner had been serving as the acting CFO since September 12, 2025, while also holding the position of president.
Resignation of Former CFO: Jim Quinlan, the former CFO and co-founder of the company, has resigned due to health reasons.
Company Financial Updates: Medicus Pharma Ltd. has reported its Q3 results and additional financial information is available through Seeking Alpha’s Quant Rating and historical earnings data.
See More
