Accelerated Approval PathwayFDA has communicated that frataxin concentrations in skin could serve as the basis for accelerated approval, supporting Larimar's pathway for approval.
Financial PerformanceLarimar raised an additional $65.1M, lifting cash to $203.6M, which extends its financial runway.
Regulatory ProgressThe Ph3 trial for nomlabofusp is on track to begin enrollment with a study design accepted by both FDA and EMA, emphasizing a rigorous and approved approach.