Lexeo Therapeutics Finalized SUNRISE-FA Pivotal Trial Protocol And Statistical Analysis Plan Intended To Provide Clinical Evidence To Support Submission FDA Application For Gene Therapy Candidate LX2006 Under The Accelerated Approval Pathway In 2028

Lexeo Therapeutics, Inc.

Lexeo Therapeutics, Inc.

LXEO

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  • SUNRISE-FA 2 study parameters include LVMI primary endpoint, 6-month topline efficacy analysis, inclusion criteria focused on abnormal baseline LVMI and open-label trial design 
  • BLA supportive manufacturing strategy includes flexible process validation, including reduced PPQ manufacturing batches
  • SUNRISE-FA 2 initiation on track for Q2 2026, with first patient expected to be enrolled by end of June
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