Medicus Pharma Ltd (MDCX)
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Medicus Pharma seeks rare pediatric disease tag for SkinJect in Gorlin Syndrome
Medicus Pharma (NASDAQ:MDCX) said Monday it has submitted a Rare Pediatric Disease Designation request to the US Food and Drug Administration for SkinJect, its investigational microneedle patch for treating basal cell carcinoma in patients with Gorlin Syndrome. The submission follows an Orphan Drug Designation application and a registrational study design currently under FDA review for SkinJect, a dissolvable patch that delivers the chemotherapy drug doxorubicin directly into skin cancer lesions.
Medicus Pharma files IND for genomics-enabled endometriosis trial in UAE
Medicus Pharma (NASDAQ:MDCX) has submitted an Investigational New Drug application to Abu Dhabi's Department of Health for PRECISION-E2, a Phase 2a clinical trial evaluating its Teverelix drug candidate in women with symptomatic endometriosis in the United Arab Emirates. The study will enroll approximately 84 women across multiple sites in the UAE and test three different Teverelix dosing regimens, delivered by injection, to determine which dose and method best controls estrogen levels while minimizing side effects.
Medicus Pharma submits EU clinical trial modification for prostate cancer drug Teverelix
Medicus Pharma (NASDAQ:MDCX) has filed a substantial modification application through the European Union Clinical Trials Information System to advance a Phase 2b study of its prostate cancer treatment Teverelix, the company said on Monday. The planned trial will focus on patients with advanced prostate cancer and elevated cardiovascular risk who require androgen deprivation therapy (ADT), a segment the company estimates represents roughly $4 billion in annual market opportunity across major pharmaceutical markets.
Medicus Pharma advances SkinJect for Gorlin syndrome – ICYMI
Medicus Pharma (NASDAQ:MDCX) earlier this week announced the filing of a registration study with the US Food and Drug Administration (FDA) for its SkinJect program targeting patients with Gorlin syndrome, marking a potentially important step toward commercialization of the technology. Speaking with Proactive, chief executive Raza Bokhari said the company has continued to advance SkinJect, a non-invasive treatment platform designed for non-melanoma skin diseases, particularly basal cell carcinoma.
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Medicus Pharma advances SkinJect program with FDA submission targeting Gorlin Syndrome
Medicus Pharma (NASDAQ:MDCX) announced that it has submitted Protocol SKNJCT-005 to the US Food and Drug Administration (FDA) under its existing Investigational New Drug (IND) application for SkinJect, advancing the therapy into registrational development for patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome (NBCCS). The company said the protocol outlines a Phase 2b, open-label study intended to generate efficacy and safety data that could support a future New Drug Application (NDA) for SkinJect in the rare inherited disorder.
Medicus Pharma secures up to $22M in non-dilutive financing facility
Medicus Pharma (NASDAQ:MDCX) announced on Thursday that it has entered into a definitive financing agreement with an institutional investor for an up to $22 million structured, non-dilutive financing facility aimed at supporting its clinical development programs and extending its cash runway. The biotech and life sciences company said the financing is expected to increase its pro forma cash position to about $30 million and provide projected operating liquidity for more than 24 months.
Medicus Pharma sees catalyst-rich year ahead as SkinJect and Teverelix progress
Medicus Pharma (NASDAQ:MDCX) reported first quarter 2026 financial results on Thursday, highlighting progress across its SkinJect and Teverelix clinical programs while continuing efforts to strengthen its financing position. The biotech company said it recently reported positive expanded Phase 2 data for its SkinJect Doxorubicin Microneedle Array treatment for nodular basal cell carcinoma, including what it described as registrational-grade clearance rates in the 200-microgram treatment cohort.
Medicus Pharma highlights positive dose-response in updated skin cancer trial results
Medicus Pharma (NASDAQ:MDCX) has reported additional results from a pre-specified expanded dataset analysis of its Phase 2 SKNJCT-003 trial, showing a positive dose-response relationship for its Doxorubicin Microneedle Array (D-MNA) in treating nodular basal cell carcinoma (BCC). The analysis builds on previously disclosed topline results and incorporates biological, histologic, and safety data from a refined group of 69 patients whose diagnoses met the study's intended inclusion criteria.
Medicus Pharma lobbies Congress on SkinJect regulatory pathway for rare Gorlin syndrome
Medicus Pharma (NASDAQ:MDCX) said on Monday its chief executive and senior leadership team met with US lawmakers on Capitol Hill to seek support for regulatory and policy measures aimed at advancing its SkinJect therapy for patients with Gorlin syndrome, a rare inherited condition linked to recurrent skin cancers. The biotech company said the discussions focused on securing orphan drug designation for SkinJect for Gorlin syndrome, registrational investigational new drug approval for affected patients, and support for the rare disease pediatric FDA voucher program.
Medicus Pharma seeks orphan drug status for SkinJect in rare skin cancer disorder
Medicus Pharma (NASDAQ:MDCX) said on Friday it has submitted an application to the US Food and Drug Administration seeking orphan drug designation for its SkinJect therapy to treat basal cell carcinoma in patients with Gorlin Syndrome, a rare genetic condition marked by recurring skin cancers. The company said the filing expands its SkinJect program into an area of high unmet medical need, where treatment options are limited and often rely on repeated surgical procedures that can lead to cumulative physical and psychological burden.
Medicus Pharma to present new Teverelix data at upcoming endocrinology meeting
Medicus Pharma (NASDAQ:MDCX) announced plans to present new early-stage clinical data on its investigational drug candidate, Teverelix, at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas later this month. The company said the presentation will include results from two Phase 1 studies evaluating Teverelix, a long-acting gonadotropin-releasing hormone (GnRH) antagonist being developed for hormone-related conditions.
