Clinical DataThe prior Phase II clinical data of 50 mg nomlabofusp showed skin FXN levels approximating those of 50% of healthy volunteers (asymptomatic range), which is viewed as clearly exceeding the bar for success.
Financial PositionLarimar raised an additional $65.1M, lifting cash to $203.6M, which extends its financial runway.
Regulatory ApprovalThe FDA expressed openness to use skin FXN concentrations as a reasonably likely surrogate endpoint, which could lead to a path forward for accelerated approval.