Medicus Pharma (NASDAQ:MDCX) said on Thursday it is entering a “catalyst-rich” 2026 after reporting annual results and highlighting progress across its SkinJect and Teverelix programs, alongside expansion into precision medicine and AI-enabled clinical development.
The clinical-stage biotech said 2025 marked a pivotal year, driven by completion of a Phase 2 study for SkinJect and efforts to broaden its pipeline into rare diseases and women’s health.
“The strength of our clinical dataset, combined with regulatory alignment and potential access to capital resources, positions the company to advance toward registrational planning and strategic partnerships in 2026 and beyond,” CEO Dr Raza Bokhari said.
SkinJect, a microneedle-based immuno-oncology therapy targeting non-melanoma skin cancers, reported positive topline results from a 90-patient Phase 2 study. The company said the highest dose cohort achieved clinical clearance rates of up to 73%, with data suggesting roughly three out of four patients could potentially avoid immediate surgery. Durable biological activity was also observed.
Medicus plans to hold an end-of-Phase 2 meeting with the US Food and Drug Administration to define a potential registrational pathway, including alignment under the 505(b)(2) framework. It is also expanding SkinJect into rare indications such as Gorlin Syndrome, with an Expanded Access program under consideration.
Separately, the company is exploring a collaboration with Helix Nanotechnologies to integrate its delivery platform with mRNA technologies, potentially extending into vaccine applications.
Medicus is also advancing Teverelix, a next-generation GnRH antagonist for prostate cancer patients with elevated cardiovascular risk. A Phase 2b study is planned in prostate cancer and acute urinary retention, while the company is expanding into women’s health, including endometriosis, using a genomics-driven development strategy.
In parallel, Medicus has partnered with Reliant AI to develop an AI-driven platform aimed at improving trial design, patient selection and development efficiency.
The company raised about $31.9 million in 2025 and ended the year with $8.7 million in cash. It reported a net loss of $35.4 million, reflecting increased investment in research and development.
Medicus will host a business update call later on Thursday, with participation from clinical investigators involved in its Phase 2 SkinJect study.