Articles from IntraBio

IntraBio Announces U.S. FDA Approval of AQNEURSA® (levacetylleucine) for Ataxia-Telangiectasia
IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved AQNEURSA® (levacetylleucine) for the treatment of ataxia in adult and pediatric patients with ataxia-telangiectasia (A-T) weighing ≥15 kg. AQNEURSA is the first and only drug approved for the treatment of A-T anywhere in the world. In the United States, it is the second indication AQNEURSA is approved to treat, following its initial approval in September 2024 for the treatment of the neurological manifestations in Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
By IntraBio · Via Business Wire · September 18, 2026
CORRECTING and REPLACING IntraBio Announces Publication of New Research Showing a Direct, Bidirectional Effect on Lysosomal Function with Levacetylleucine
The last paragraph in the release after the boilerplate has been removed.
By IntraBio · Via Business Wire · July 20, 2026