MDCX

Medicus Pharma (NASDAQ:MDCX) said the US Food and Drug Administration (FDA) has issued a "Study May Proceed" letter authorizing the company to begin its NDA-enabling Phase 2b registrational study of SkinJect in patients with Gorlin syndrome who develop multiple basal cell carcinomas. The authorization follows the FDA's review of the company's investigational new drug (IND) application for the SKNJCT-005 study and Medicus' response to information requests issued by the agency in June.

SKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up SKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up

Medicus Pharma (NASDAQ:MDCX) said it has received US FDA feedback and central Institutional Review Board approval for its optimized Phase 2 study of Teverelix in men following a first episode of acute urinary retention. The redesigned study, designated ANT-2111-02, is expected to enroll approximately 126 patients across the United States and Europe, down from roughly 390 patients contemplated under the company's previously disclosed development plan.

Regulatory and ethical-review milestones advance a capital-efficient Phase 2 study expected to enroll ~126 patients versus ~390 under the previously disclosed development plan Regulatory and ethical-review milestones advance a capital-efficient Phase 2 study expected to enroll ~126 patients versus ~390 under the previously disclosed development plan

Company's presentation will provide updates on SkinJect® Phase 2b Pivotal Study in patients with Gorlin Syndrome and Teverelix® Groundbreaking PRECISION-E2 Phase 2a Endometriosis Study leveraging the UAE Genome Program Company's presentation will provide updates on SkinJect® Phase 2b Pivotal Study in patients with Gorlin Syndrome and Teverelix® Groundbreaking PRECISION-E2 Phase 2a Endometriosis Study leveraging the UAE Genome Program

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.

PHILADELPHIA, June 15, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced the submission of a Rare Pediatric Disease Designation (“RPDD”) request to the U.S. Food and Drug Administration (“FDA”) for SkinJect®, the Company's investigational doxorubicin-containing microneedle array patch (D-MNA), for the treatment of basal cell carcinoma (“BCC”) in patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome.

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.

Novel genomics-enabled clinical trial in United Arab Emirates (UAE) seeks to identify genetic predictors of treatment response while evaluating Teverelix® as a potential long-acting precision medicine therapy for women with endometriosis Novel genomics-enabled clinical trial in United Arab Emirates (UAE) seeks to identify genetic predictors of treatment response while evaluating Teverelix® as a potential long-acting precision medicine therapy for women with endometriosis

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.