Completed Dosing of Adolescents in Pharmacokinetic (PK) Run-In Study.
Potential for Accelerated Approval Pathway Based on Skin FXN Concentrations.
Planned Upcoming Regulatory Discussions.
50 mg OLE Data Expected in September 2025.
Planned Transition to Lyophilized Form of Nomlabofusp.
BLA Submission and Initiation of Global Phase 3 Study on Track
