Medicus Pharma

MDCX

Market cap $25.9M

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) 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.

European regulatory filing supports planned 2026 initiation of Phase 2b study of Teverelix® in an underserved population representing ~$4 billion annual market opportunity European regulatory filing supports planned 2026 initiation of Phase 2b study of Teverelix® in an underserved population representing ~$4 billion annual market opportunity

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.

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.

PHILADELPHIA, June 03, 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 therapeutics assets, today announced the submission of Protocol SKNJCT-005 to the U.S. Food and Drug Administration (FDA) under the Company's existing Investigational New Drug (IND) application, for SkinJect® into registrational development for patients with Gorlin Syndrome, also called Nevoid Basal Cell Carcinoma Syndrome (NBCCS), a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers, often resulting in repeated surgical procedures.

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.