Welcome to our dedicated page for Medicus Pharma news (Ticker: MDCX), a resource for investors and traders seeking the latest updates and insights on Medicus Pharma stock.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech and life sciences company whose news flow centers on clinical trial progress, regulatory milestones, strategic collaborations and capital markets activity. The company describes itself as a precision guided biotech/life sciences organization focused on advancing SkinJect™, an investigational microneedle therapy for basal cell carcinoma (BCC) of the skin, and Teverelix, a long-acting GnRH antagonist for hormone-driven conditions.
News updates frequently cover the SkinJect™ program, including Phase 2 study SKNJCT-003 in the United States, regulatory and ethics approvals to expand into the United Kingdom, and SKNJCT-004 in the United Arab Emirates. Releases also highlight interactions with the U.S. Food and Drug Administration (FDA), such as Type C meeting feedback supporting a 505(b)(2) regulatory pathway and the filing of an FDA Commissioner’s National Priority Voucher (CNPV) application for SKNJCT-003.
Another major theme in MDCX news is the Teverelix pipeline, added through the acquisition of Antev Limited. Company communications describe prior Phase 1 and Phase 2a data, FDA guidance on Phase 3 design, and plans to use AI-enabled analytics—via an engagement with Reliant AI Inc.—to support upcoming Teverelix clinical studies. Additional coverage includes Phase 1 data in healthy female volunteers and acceptance of Teverelix research for presentation at a leading endocrinology conference.
Investors following MDCX news will also see announcements on collaborations, such as the Gorlin Syndrome Alliance partnership for compassionate access to SkinJect™ and a non-binding memorandum of understanding with Helix Nanotechnologies, Inc. around thermostable infectious disease vaccines. Capital markets updates, including warrant inducement agreements, standby equity purchase activity and debenture financings, are disclosed through press releases and Form 8-K filings.
This news page aggregates these developments so readers can review Medicus Pharma’s clinical, regulatory, partnering and financing announcements in one place.
Medicus Pharma (NASDAQ:MDCX) will present at the Family Office Summit in Dubai on October 9, 2025, with CEO Dr. Raza Bokhari speaking on biotech innovation, AI in drug development, and the UAE Genomic project.
Medicus is conducting a Phase 2 study of SKNJCT-003 across 9 US sites, expanded to 90 subjects with >75% randomized after randomization began in August 2024; a March 2025 interim analysis showed >60% clinical clearance but results are preliminary. The company received positive FDA Type C feedback in September 2025 indicating a possible 505(b)(2) pathway for Skinject. Medicus also runs a 36-patient UAE trial (SKNJCT-004) and completed the acquisition of Antev (August 2025), adding Teverelix TFA, a long-acting GnRH antagonist with a six-week dosing interval.
Medicus Pharma (NASDAQ:MDCX) received positive FDA feedback from a Type C meeting regarding Skinject, their novel doxorubicin-containing microneedle array (D-MNA) treatment for basal cell carcinoma. The FDA supported the 505(b)(2) regulatory pathway, which could accelerate development and reduce costs.
The company's Phase 2 study SKNJCT-003 has shown promising interim results with over 60% clinical clearance and has expanded to 90 participants across multiple sites. Medicus plans to complete patient recruitment in Q4 2025 and request an End-of-Phase 2 meeting in Q1 2026, targeting potential commercialization in 2027.
Additionally, Medicus recently acquired Antev, a UK biotech company developing Teverelix, a next-generation GnRH antagonist for prostate cancer patients with cardiovascular risks.
Medicus Pharma (NASDAQ:MDCX) received positive FDA feedback from a Type C meeting regarding their Skinject development program, a novel treatment for basal cell carcinoma (BCC) using doxorubicin-containing microneedle arrays (D-MNA). The FDA confirmed the 505(b)(2) regulatory pathway viability, representing a $2 billion market opportunity.
The company is advancing two clinical trials: SKNJCT-003 in the US with 90 participants (75% enrolled) and SKNJCT-004 in the UAE with 36 patients across six sites. An interim analysis showed over 60% clinical clearance in the SKNJCT-003 study. Medicus plans to complete patient recruitment by Q4 2025 and request an End-of-Phase 2 meeting in Q1 2026.
Additionally, Medicus recently acquired Antev, a UK biotech company developing Teverelix, a next-generation GnRH antagonist for prostate cancer patients with cardiovascular risks.
Medicus Pharma Ltd. (NASDAQ:MDCX) announced its upcoming participation in a live fireside chat hosted by Brookline Capital Markets on September 29, 2025. The company will present updates on two key development programs: SkinJect™ D-MNA for basal cell carcinoma treatment and Teverelix, a GnRH antagonist for urinary retention and prostate cancer.
The company's Phase 2 clinical study SKNJCT-003 has shown promising interim results with over 60% clinical clearance and has expanded to include 90 participants across U.S. sites. A parallel study, SKNJCT-004, is ongoing in the UAE across 6 medical centers. Additionally, Medicus recently acquired Antev, gaining access to Teverelix TFA, which offers a unique six-week dosing interval. These programs collectively represent a $8 billion market opportunity.
Medicus Pharma (NASDAQ:MDCX) has secured an $8.0 million non-dilutive debenture financing through a purchase agreement with Yorkville Advisors Global's investment fund. The debenture carries an 8% annual interest rate and matures in 12 months, with monthly installment payments.
The financing refinances approximately $1.7 million of existing debentures from May-June 2025, resulting in net proceeds of $5.7 million. The company plans to use the funds to accelerate the development of Teverelix, a next-generation GnRH Antagonist targeting Acute Urinary Retention and high CV risk Prostate Cancer markets, with an estimated $6 billion market opportunity.
Medicus Pharma (NASDAQ:MDCX) has initiated patient recruitment for its SKNJCT-004 Phase 2 clinical study at Cleveland Clinic Abu Dhabi (CCAD) to treat Basal Cell Carcinoma (BCC) of the skin. The study will enroll 36 participants across multiple UAE sites in a randomized, double-blind, placebo-controlled trial evaluating two dose levels of D-MNA.
The company's parallel U.S. study, SKNJCT-003, has already enrolled 75% of its 90 targeted participants and showed promising interim results with over 60% clinical clearance. This represents a potential $2 billion market opportunity. Additionally, Medicus recently acquired UK-based Antev Limited and entered a non-binding MoU with Helix Nanotechnologies for potential mRNA platform development.
Medicus Pharma (NASDAQ:MDCX) has completed the acquisition of 98.6% of Antev Limited for $2.97 million in cash and 1,603,164 common shares. The deal includes potential additional contingent payments of up to $65 million tied to FDA approvals.
Antev is developing Teverelix, a next-generation GnRH antagonist targeting two key indications: Acute Urinary Retention (AURr) and high CV risk Prostate Cancer, representing a combined market opportunity of $6 billion. The company has FDA-approved Phase 2b studies for both indications, with AURr study planning to enroll 390 patients and the prostate cancer study targeting 40 patients.
Following the acquisition, industry veteran Patrick J. Mahaffy, former chairman of Antev and ex-CEO of Clovis Oncology, joins Medicus's board of directors.
Medicus Pharma (NASDAQ: MDCX) reported significant progress in its D-MNA clinical development program for treating Basal Cell Carcinoma. The FDA has accepted the company's Type C meeting request, with a response expected by Q3 2025. The Phase 2 study (SKNJCT-003) has reached 75% enrollment of 90 participants across 9 U.S. clinical sites.
The company announced positive interim analysis showing over 60% clinical clearance. Additionally, Medicus entered a definitive agreement to acquire Antev Ltd. and signed an MoU with HelixNano for mRNA vaccine development. Financial highlights include $9.7 million in cash, increased operating expenses of $6.0 million, and a net loss of $6.2 million for Q2 2025.
Medicus Pharma (NASDAQ: MDCX) has signed a non-binding Memorandum of Understanding (MOU) with Helix Nanotechnologies to develop thermostable infectious disease vaccines. The collaboration aims to combine HelixNano's proprietary mRNA vaccine platform with Medicus' Microneedle array (MNA) delivery platform.
The companies plan to form a joint venture for co-development and commercialization of thermostable mRNA-based vaccines. Initially, they will collaborate on producing clinical-grade mRNA vaccine-loaded MNAs for a Phase 1 clinical bridging study comparing intramuscular injection versus intradermal MNA delivery of HelixNano's vaccine candidate HN-0001.
The partnership includes a Sponsored Research Agreement with the University of Pittsburgh under Dr. Lou Falo's direction. HelixNano will supply the mRNA-LNP formulated vaccine material, while Medicus and the University will handle MNA loading and optimization.
Poxel (MDCX) has announced major changes to its corporate governance following the filing for insolvency and request for reorganization proceedings with the Court for Economic Activities of Lyon. The company revealed that all current directors have resigned effective July 31, 2025, including CEO Thomas Kuhn.
The Board has appointed four new directors: Sophie Jacq Lapointe (new Chairman), Nicolas Trouche (new CEO), Amit Kohli, and Alexandre Bragadir. Among these, Jacq Lapointe and Kohli are considered independent directors. These changes come as part of an agreement with the company's senior creditor, reflecting significant organizational restructuring amid financial challenges.