Core Insights - Lexeo Therapeutics Inc. is making significant progress with its gene therapy candidate LX2006 for Friedreich ataxia/FA cardiomyopathy, having received positive feedback from the US FDA regarding an Accelerated Approval pathway [1][2] - The company is optimistic that the combination of regulatory support and promising interim clinical data will expedite the timeline for submitting a Biologics License Application (BLA) [2][3] - Lexeo plans to initiate a pivotal trial in H1 2026, leveraging a new optimized manufacturing platform while meeting additional FDA requirements [3] Regulatory Support - The FDA has expressed openness to an accelerated approval BLA submission that could pool data from ongoing Phase I/II trials with new data from the planned pivotal study [2][3] - The FDA has agreed to evaluate the co-primary endpoint of left ventricular mass index at an earlier time point than 12 months, which may allow for a smaller and shorter pivotal study [3] Manufacturing and Trial Plans - Lexeo intends to use its optimized, high-yield Sf9-baculovirus manufacturing platform for future commercial supply, moving away from the HEK293 process used in earlier trials [3] - The company is required to submit enhanced manufacturing comparability data and fulfill an additional nonclinical requirement before commencing the pivotal trial [3]