BridgeBio reported positive interim Phase 3 data for BBP‑418 in limb‑girdle muscular dystrophy type 2I/R9, meeting prespecified thresholds and prompting the company to seek discussions with the FDA about filing strategy. The interim readout showed statistically significant improvements on functional and biomarker endpoints versus placebo. BridgeBio said the results could underpin an NDA pathway and that the company will meet regulators to align on submission content and potential approval routes. If advanced, BBP‑418 could become the first approved therapy for this rare LGMD subtype, addressing a high unmet need and altering the competitive rare‑disease landscape.