Medicus Pharma Reports Phase 2 Results for SkinJect, FDA Clears Teverelix Trial

Medicus Pharma Ltd. (NASDAQ: MDCX) reported Phase 2 SKNJCT-003 topline results showing the 200µg D-MNA cohort reached 73% clinical clearance and 40% histological clearance (CR) at Day 57. The randomized, placebo-controlled study enrolled 90 patients across randomized groups.

Results improved from Day 29 to Day 57. The company says the dataset is decision-grade for partnering discussions but notes the study was not powered for registrational endpoints. Small cohort size at Day 57 for 200µg (n=15) constrains statistical confidence. The company states no assurance of FDA approval despite decision-grade topline data.

The Company is expected to finalize the Clinical Study Report (CSR) in Q2 2026 to support planned end of Phase 2 (EOP2) meeting with the FDA.

In separate news, the FDA has given Medicus a study may proceed notice, allowing the company to commence a dose optimization study for Teverelix. The asset comes to Medicus following the acquisition of Antev. This dose optimization study sets the stage for the company to subsequently begin a pivotal study for patients with advanced prostate cancer and high cardiovascular risk profiles.

Teverelix is a next-generation GnRH antagonist. It is an androgen deprivation therapy administered as an injectable that suppresses the LH and FSH hormones, resulting in testosterone suppression, which is very important to prevent progression of advanced prostate cancer.

In patients with advanced prostate cancer—approximately 300,000 to 500,000 in the United States living on androgen deprivation therapy—the most common cause of death is not prostate cancer, but cardiovascular comorbidity. Teverelix, as an antagonist rather than an agonist, has an opportunity to achieve a label indication if the company can demonstrate that it is also cardioprotective.

The company is aligning its CMC and manufacturing and has retained IQVIA as its CRO. This dose optimization study is designed to ensure the company can maintain castration levels beyond day 42, which was demonstrated in the previous Phase 2a study. The Phase 2b study will enroll about 40 men for approximately 22 weeks and extends evaluation to day 155, positioning the company to return to the FDA to finalize a pivotal study.

The company's focus is on completing Phase 2 studies and positioning the asset for partnership and monetization. Besides the Skinject opportunity, which is ready for monetization pending data readout, the company believes Teverelix could become a partnership candidate around this time next year.