The FDA approved IntraBio’s Aqneursa (levacetylleucine), marking the first treatment for ataxia-telangiectasia, a rare neurodegenerative disorder. IntraBio previously received FDA approval for Aqneursa in Niemann-Pick disease type C, and this latest decision extends the molecule into a new genetic indication. The approval arrives after development efforts to establish efficacy and safety in this pediatric and early-onset population. IntraBio will now move to support launch activities and ongoing evidence generation.