BridgeBio reported positive interim Phase 3 data in a rare muscular dystrophy study and said it will adjust its regulatory strategy and meet with the FDA to discuss a path to approval. The company described biomarker and clinical improvements that strengthen its filing case. BridgeBio confirmed the Phase 3 outcome met pre‑specified success criteria and that the new data prompted a shift in previous submission timing and preparatory steps. Company communications indicate the updated plan is intended to present a more robust chemistry, manufacturing and controls (CMC) and clinical dataset to regulators. The Phase 3 result could underpin an FDA filing that, if accepted, would mark a major milestone for the company’s rare‑disease portfolio.