Medicus Pharma (NASDAQ:MDCX) said on Wednesday its Phase 2 study of SkinJect (SKNJCT-003), a doxorubicin-containing microneedle array for nodular basal cell carcinoma (BCC), showed clinically meaningful activity, supporting plans to advance the therapy toward registrational development.
“We believe the positive topline results from 200 ug cohort at day 57, support the therapeutic value of SkinJect and establishes the best path forward towards registrational study,” said Dr. Raza Bokhari, executive chairman and CEO of Medicus.
Bokhari’s comments come as the company noted that aspects of its March 2026 topline data, particularly regarding the device-only arm, may have caused confusion.
“While the active device-only arm provided an important mechanistic context, its therapeutic effect is not pivotal to develop and commercialize doxorubicin containing microneedle arrays (D-MNA), relying on 505(b)2 pathway to registration,” the CEO told investors. “We are very pleased with the Phase 2 study dataset and look forward to participating in the planned EOP2 meeting with the FDA and accelerate partnering discussions.”
SkinJect is being developed as a potential non-surgical option for patients with nodular BCC, a common skin cancer typically treated with surgery. If confirmed in future trials, the therapy could provide a non-invasive alternative or expand access for patients unable to undergo surgery.
Topline Phase 2 results showed the 100 microgram cohort achieved nearly half of patients with clinical clearance by Day 29, with further improvement by Day 57. The 200 microgram cohort emerged as the lead regimen, showing continued improvement through Day 57 and the highest observed activity across endpoints. The study also included a device-only arm for mechanistic insight, which is not central to SkinJect’s regulatory or therapeutic development.
The company said the forthcoming Clinical Study Report will focus on the active cohorts, dose-response characterization, and outcomes relevant to therapeutic efficacy. The 200 microgram dose will form the basis for the registrational strategy, with refinements to study design, endpoints, biopsy timing, and treatment schedule in alignment with upcoming FDA guidance.
Medicus said the Phase 2 dataset provides decision-grade evidence to support regulatory engagement, potential strategic partnerships, and the continued development of SkinJect as a non-invasive treatment for nodular BCC.