Particle.news
Download on the App Store
3 ARTICLES
·
2h ago

FDA Signals Openness to Accelerated Path for Lexeo’s Friedreich’s Ataxia Cardiac Gene Therapy

Lexeo plans to combine pooled study data with a forthcoming pivotal trial in a submission focused on treating cardiomyopathy.

Image
Image

Overview

  • Lexeo said the FDA indicated openness to reviewing LX2006 for accelerated approval using pooled data from ongoing studies plus a planned pivotal trial.
  • The company said the feedback could allow a smaller, shorter pivotal study and potentially speed a filing.
  • Regulators requested added manufacturing details because Lexeo intends to move to an optimized production process for future studies and eventual supply.
  • Early results suggest the therapy may improve signs of heart damage in Friedreich’s ataxia, which is not addressed by the approved drug Skyclarys.
  • Lexeo targets the first half of 2026 to start the pivotal trial, and its shares rose about 30% after the update as investors responded to recent FDA draft guidance on gene therapy pathways.