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) reported Q2 2026 results and regulatory progress across its SkinJect and Teverelix programs. According to Medicus Pharma, cash, cash equivalents and restricted cash totaled $25.2 million on June 30, 2026, with cash and cash equivalents of $15.2 million, up from $9.7 million a year earlier. Year to date, the company raised approximately $40 million through equity and debt, including use of its ATM program and a secured facility, though substantial doubt remains about its ability to continue as a going concern without further financing.
Q2 operating expenses (loss from operations) were $11.5 million versus $6.0 million in Q2 2025, and net loss was $11.7 million versus $6.2 million, with net loss per share of $0.21 versus $0.43. Medicus reported positive Phase 2 SkinJect data (64% clinical and 55% histological clearance at the 200 μg dose) and FDA “Study May Proceed” authorization for the registrational SKNJCT-005 trial in Gorlin Syndrome. It also received IRB authorization and favorable FDA feedback for an optimized Phase 2 Teverelix study in acute urinary retention and UAE DOH authorization for the PRECISION-E2 Phase 2 study in endometriosis.
Medicus Pharma (Nasdaq: MDCX) appointed Dr. Faisal Mehmud, MD, MRCP as Chief Executive Officer of its UK subsidiary Antev Limited, effective August 30, 2026, while he continues as Medicus Chief Medical Officer and Co-Chairman of Antev.
According to Medicus, consolidating these roles is intended to provide unified scientific, clinical, regulatory and operational leadership as the company advances Teverelix®, a next-generation GnRH antagonist in late-stage clinical development for advanced prostate cancer, acute urinary retention and women’s health indications such as endometriosis. Dr. Mehmud succeeds interim CEO Amit Kohli, who agreed at Antev’s August 29, 2025 acquisition to remain for one year to support transition. Dr. Mehmud brings over 20 years of global biopharmaceutical leadership across clinical development, medical affairs, regulatory strategy and pharmacovigilance at companies including Pfizer, GSK, Bristol Myers Squibb, Novartis and Sanofi.
Medicus Pharma (NASDAQ: MDCX) received Investigational New Drug authorization from the UAE Department of Health – Abu Dhabi for its randomized, placebo-controlled Phase 2a PRECISION-E2 clinical study of Teverelix® in approximately 84 women with moderate-to-severe symptomatic endometriosis. The DOH authorization follows a comprehensive review of chemistry, manufacturing and controls, non-clinical, clinical and safety data and allows the study to proceed, subject to site-specific IRB and ethics approvals.
PRECISION-E2 will test multiple Teverelix® doses and routes versus placebo, focusing on maintaining serum estradiol in the Barbieri therapeutic window for at least 14 consecutive days, while integrating pharmacodynamic, pharmacokinetic, biomarker, clinical and whole-genome data to explore candidate treatment-response biomarkers for future precision medicine strategies in women’s health.
Medicus Pharma (NASDAQ: MDCX) received an FDA “Study May Proceed” letter for its NDA-enabling, registrational Phase 2b study SKNJCT-005, evaluating SkinJect® (D‑MNA) 200 mcg in Gorlin Syndrome patients with multiple basal cell carcinomas. The open-label, multicenter trial is expected to enroll up to 50 patients.
According to Medicus, FDA feedback led to protocol enhancements including mandatory baseline biopsy confirmation of nodular BCC, a composite primary endpoint requiring both clinical and histological clearance, in-person investigator assessments, aligned responder definitions, and extended follow-up from 24 weeks to at least two years to assess durability. Prior SKNJCT-003 data in 90 patients showed 64% clinical and 55% histological clearance at Day 57 after three 200‑mcg treatments.
The FDA also issued non–clinical-hold recommendations on pharmacokinetics, microneedle evaluation, genetic confirmation of Gorlin Syndrome, independent safety monitoring, statistical methods, and future randomized, blinded, comparator-controlled designs. Medicus plans to amend the SKNJCT-005 protocol and provide further updates as study initiation and enrollment planning advance.
Medicus Pharma (NASDAQ: MDCX) received written feedback from the FDA and central IRB approval, with modifications, for its optimized Phase 2 ANT-2111-02 study of Teverelix in men after a first episode of acute urinary retention secondary to benign prostatic hyperplasia.
The redesigned randomized, double-blind, placebo-controlled multicenter trial will enroll about 126 patients in the US and Europe versus roughly 390 in the prior plan, and will test intramuscular and subcutaneous Teverelix regimens against placebo. According to Medicus Pharma, FDA comments dated July 8, 2026 are operational, not affecting scientific rationale, population, treatment arms, primary endpoint or interim analysis. Central IRB Advarra approved the protocol on June 18, 2026, with approval through June 18, 2027, enabling study start-up and site activation activities.
Medicus Pharma (NASDAQ:MDCX) will present at Bio International 2026 in San Diego on June 24, 2026, at 3:00 p.m. Pacific in Theater 2.
The presentation will cover SkinJect® Phase 2b strategy in Gorlin Syndrome and Teverelix® programs in advanced prostate cancer, AURr, and endometriosis, including the PRECISION-E2 genomic study.
Medicus Pharma (NASDAQ:MDCX) submitted a Rare Pediatric Disease Designation (RPDD) request to the FDA for SkinJect, its doxorubicin microneedle patch, to treat basal cell carcinoma in Gorlin Syndrome patients.
Medicus highlights Phase 2 data showing 64% clinical clearance and 55% complete response in nodular BCC with a favorable safety profile, and outlines potential RPDD and Orphan Drug incentives, including a future Priority Review Voucher and U.S. market exclusivity.
Medicus Pharma (NASDAQ:MDCX) submitted an IND to Abu Dhabi’s Department of Health for PRECISION-E2, a randomized, placebo-controlled Phase 2a trial of Teverelix in women with moderate-to-severe endometriosis in the UAE.
The ~84‑patient study integrates Emirati Genome Program data to link genomic variation with hormonal response, safety, and symptom outcomes.
Medicus Pharma (NASDAQ:MDCX) submitted a substantial modification application via the EU Clinical Trials Information System to support a planned Phase 2b study of Teverelix® in advanced prostate cancer patients with elevated cardiovascular risk.
The study, expected to start enrollment in 2026 subject to regulatory authorization, aims to optimize dosing and further characterize pharmacokinetics, pharmacodynamics, efficacy and safety ahead of potential registrational development for an estimated ~$4 billion annual market segment.
Medicus Pharma (NASDAQ:MDCX) submitted Protocol SKNJCT-005 to the FDA, advancing SkinJect into Phase 2b registrational development for Gorlin Syndrome, a rare genetic disorder with multiple basal cell carcinomas.
The open-label study will enroll up to 50 patients using SkinJect 200 mcg, supported by prior Phase 2 data showing 64% clinical clearance and 55% histological clearance at Day 57 with no treatment-related serious adverse events. Medicus has applied for FDA Orphan Drug Designation and plans to seek a Rare Pediatric Disease Priority Review Voucher, which, if granted, may provide fee exemptions, market exclusivity and a shortened NDA review timeline.