Medicus Pharma (NASDAQ:MDCX) announced that it has submitted a formal request to the US Food and Drug Administration (FDA) for a Type C meeting to discuss the clinical development pathway for its dissolvable doxorubicin-containing microneedle array (D-MNA) product targeting basal cell carcinoma (BCC) of the skin.
The company is seeking a meeting during the week of October 6, aiming to gain the agency’s approval to fast-track the program and seek feedback on future clinical plans.
As part of the submission, Medicus provided a comprehensive package that includes a list of questions for the FDA regarding dosing, study design, safety assessments, and proposed clinical endpoints, including the use of complete histological clearance at six weeks post-treatment as the primary endpoint.
Medicus’s ongoing Phase 2 study, SKNJCT-003, is a randomized, double-blind, placebo-controlled, multi-center trial evaluating two dose levels of D-MNA (100μg and 200μg) against a placebo in up to 90 subjects with BCC.
Originally initiated in August 2024 across nine US clinical sites, the trial expanded following an interim analysis released in March 2025 that showed more than 60% clinical clearance among randomized patients.
The 200μg dose was previously tested in Medicus’s Phase 1 study (SKNJCT-001), completed in March 2021, which met its safety and tolerability objectives with no dose-limiting toxicities or serious adverse events. Six out of 13 participants in that study experienced complete histological response.
In addition to its US program, Medicus is conducting the SKNJCT-004 study in the UAE, targeting 36 patients across four sites, including Cleveland Clinic Abu Dhabi and other major hospitals.
Shares of Medicus Pharma moved higher on the news, up 5% at about $3.60 shortly after markets opened on Tuesday.