NOV 27 2026
BridgeBio Pharma — BBP-418 $BBIO
for limb-girdle muscular dystrophy type 2I/R9
Accepted MAY 27 2026.
About
Limb-girdle muscular dystrophy type 2I/R9 is a genetic disorder that causes progressive weakness and wasting of the muscles in the shoulders and hips. BBP-418 is designed to increase levels of a sugar molecule that is deficient in this condition, which helps stabilize muscle fibers. This approach may potentially slow the progression of muscle weakness and improve physical function for those affected.
Pivotal trial
This study will evaluate the safety and efficacy of long-term administration of BBP-418 in patients with LGMD2I/R9. The study will include patients ages 12 to 60, consistent with the existing preclinical toxicology profile
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on BBP-418
- FDA decision on BBP-418 for LGMD2i expected in late November - Muscular Dystrophy News
- BridgeBio Pharma Announces FDA Acceptance of BBP-418 NDA for Limb-Girdle Muscular Dystrophy Type 2I/R9 with Priority Review Status - Quiver Quantitative
- BridgeBio Wins FDA Priority Review for BBP-418 Therapy - TipRanks
- BridgeBio Submits NDA for BBP-418 in LGMD2I/R9, Potentially the First Approved Therapy for Any Form of Limb-Girdle Muscular Dystrophy - neurologylive.com