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) 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.
Medicus Pharma (NASDAQ:MDCX) entered a definitive, non-dilutive structured financing facility of up to $22 million with an institutional investor. Medicus expects pro forma cash of about $30 million and a projected operating cash runway of more than 24 months.
The deal provides $12 million in immediate capital and $10 million in a milestone-based collateral account, via two secured promissory notes maturing in 18 months.
Medicus Pharma (NASDAQ:MDCX) reported Q1 2026 results and clinical progress for SkinJect and Teverelix.
- Phase 2 SkinJect study showed positive dose-response and clearance activity in the 200‑µg cohort; 90 patients enrolled.
- FDA cleared a Phase 2b Teverelix prostate cancer trial; royalty on future Teverelix sales cut from ~4% to 2%.
- Raised about $10 million via ATM/SEPA, cash was $6.4 million; net loss was $9.0 million with substantial going‑concern doubt.
- ATM capacity expanded to $50 million and multiple 2026 regulatory and partnering catalysts are expected.
Medicus Pharma (NASDAQ: MDCX) reported a pre-specified expanded analysis of its Phase 2 SKNJCT-003 study in nodular basal cell carcinoma showing a dose-dependent response. The 200µg D-MNA cohort achieved 55% histologic complete response at Day 57 and 64% clinical clearance. Safety remained favorable with no drug-related serious adverse events or systemic doxorubicin toxicity. The company says the dataset supports a registrational pathway and informs dose, lesion selection, and timing for future studies.
Medicus Pharma (NASDAQ: MDCX) said CEO Dr. Raza Bokhari and leadership met with senior members of the House Energy & Commerce Committee on April 27, 2026 to seek support for Orphan Drug designation, a registrational IND for SkinJect® in Gorlin Syndrome, and rare-disease pediatric voucher access.
Meetings included outreach with advocates and the Gorlin Syndrome Alliance and outline plans for regulatory and clinical development toward expedited access for high-burden patients.
Medicus Pharma (NASDAQ: MDCX) submitted an Orphan Drug Designation (ODD) application to the U.S. FDA on April 17, 2026 for SkinJect (D-MNA) to treat basal cell carcinoma in patients with Gorlin Syndrome.
SkinJect is a doxorubicin-containing dissolvable microneedle array evaluated in Phase 1/2 with reported lesion clearance and histologic complete responses; the company estimates ~11,000 U.S. patients and highlights potential benefits including localized delivery, repeat use, and possible 7-year U.S. exclusivity if approved.
Medicus Pharma (NASDAQ: MDCX) will present Phase 1 data for Teverelix at AACE 2026 (poster on April 24, 11:40 AM PT). Two studies (N=48 healthy premenopausal women) showed dose-dependent estradiol suppression, long-acting PK (t1/2 ~14–23 days), favorable bone markers (≤10% change), and acceptable safety.
The company plans precision-genomics development in endometriosis with Omics Labs and notes several non-binding collaborations and LOIs.