Medicus Pharma has received written feedback from the U.S. Food and Drug Administration and central Institutional Review Board approval for its optimized Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention. The randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients under the previously disclosed development plan. The FDA provided seven operational recommendations that the company believes do not require changes to the study's scientific rationale, patient population, treatment arms, primary endpoint or planned interim analysis. Central IRB Advarra approved the protocol with modifications on June 18, 2026, with the approval period extending through June 18, 2027. Medicus intends to incorporate the feedback and advance toward study initiation, aiming to generate decision-grade clinical evidence to support future regulatory discussions and strategic partnering opportunities.
Medicus Pharma Ltd. Common StockFDA feedback and IRB approval for optimized Phase 2 study de-risks clinical development and supports regulatory progress.