BridgeBio reported an encouraging Phase 3 interim readout for ribitol in limb‑girdle muscular dystrophy type 2I/R9 and said it will meet with the FDA to discuss regulatory plans and potential filing strategies. Company commentary described the data as a 'home run' on key functional and biomarker endpoints, prompting a shift toward earlier submission planning. The result could set a precedent for approval pathways in slowly progressive rare muscular diseases where clinically meaningful functional gains are difficult to capture rapidly. BridgeBio will now refine the NDA package, discuss confirmatory requirements with regulators and prepare manufacturing and labeling plans contingent on FDA feedback.