Lexeo finalizes SUNRISE-FA 2 pivotal trial for LX2006 in FA cardiomyopathy; BLA submission expected H1 2028

Lexeo Therapeutics, Inc.

Open-label pivotal trial of LX2006: 13 treated vs 13 untreated control; primary endpoint LVMI at 6 months.
BLA submission under accelerated approval on track for H1 2028; topline data readout expected H2 2027.
FDA removed co-primary endpoint of cardiac frataxin protein expression; trial powered for LVMI effect size ≥15%.
Pediatric cohorts included; untreated control participants eligible to cross over to LX2006 after 6 months.
CLARITY-FA natural history study ongoing, shares inclusion criteria; first patient enrollment by end of June 2026.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.