BridgeBio posted an interim Phase 3 readout for BBP‑418 in LGMD2I/R9 that the company described as a potential 'home run,' prompting plans to meet the FDA to discuss an NDA submission. The interim analysis showed statistically significant improvements on a biomarker and functional endpoints linked to muscle stability. BridgeBio said the data strengthen its regulatory pathway and could enable accelerated or full approval discussions. The company is preparing filings and regulatory engagement aimed at delivering the first therapy for this rare limb‑girdle muscular dystrophy subtype. The success underscores how well‑designed registrational trials in genetically defined rare diseases can unlock near‑term commercialization opportunities when interim markers align with clinical outcomes.