Posted by Michael Wonder on 31 Mar 2026
BridgeBio submits NDA to FDA for BBP-418 for individuals living with LGMD2I/R9
30 March 2026 - Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418’s rapid, consistent treatment effect and favourable safety profile, with statistically significant and clinically meaningful improvements in ambulation and pulmonary function.
BridgeBio Pharma today announced the submission of its new drug application to the FDA for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).
