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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

Benzinga·06/15/2026 11:04:43
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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