BridgeBio reported positive Phase 3 interim results for its limb‑girdle muscular dystrophy candidate, showing statistically significant improvements on a muscle‑stability biomarker and functional endpoints. The company said it will meet with the U.S. Food and Drug Administration to discuss next steps for an NDA filing, including potential pathways to full approval. The interim dataset boosted stock and prompted management to revisit filing timing and regulatory strategy. BridgeBio emphasized the robustness of the biomarker response and its potential to support an expedited regulatory path if confirmatory data align. BridgeBio’s timing and FDA discussions will determine whether the company seeks accelerated or traditional approval; either outcome would mark a milestone for therapies targeting rare muscular dystrophies.