Clinical Trial ProgressInitial biopsy data from cohort 2 hints at a potential dose response, and longer term data from cohort 1 suggests positive treatment effects on both biomarker and clinical measures.
Regulatory PerspectiveFDA clinical hold is procedural, not efficacy or safety driven; expected to be just a short-term blip and a non-issue.
Safety And TolerabilitySafety data for all patients showed that TN-201 was generally well tolerated at both doses, with no dose-limiting toxicities observed.