Lexeo Therapeutics posts LX2006 regulatory update presentation for Friedreich ataxia treatment program

Lexeo Therapeutics, Inc.

Lexeo Therapeutics, Inc.

LXEO

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  • Lexeo Therapeutics published a regulatory update outlining a finalized pivotal protocol for LX2006 in Friedreich ataxia cardiomyopathy.
  • Study start targeted for Q2 2026; topline data expected in 2H 2027; potential BLA filing targeted for 1H 2028.
  • Open-label pivotal design: 26 adults, 13 treated with a single IV high-dose infusion; 13 untreated controls; primary endpoint LVMI at 6 months.
  • Update highlights prior open-label data: 18% mean LVMI reduction at 6 months in abnormal-baseline patients; 28% in higher-dose subgroup.
  • Lexeo flagged ongoing FDA discussions on confirmatory evidence; CLARITY-FA natural history study positioned as supportive for approval.


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