BridgeBio reported positive Phase III interim results for BBP‑418 in limb‑girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), prompting company plans to meet the FDA to discuss regulatory filing strategies. The interim readout showed statistically significant improvements on key functional and biomarker endpoints that BridgeBio describes as a "home run." BridgeBio said the data strengthen its case for an NDA and may allow an earlier or expanded regulatory pathway than previously assumed. The company has briefed regulators and is preparing submission materials pending the agency discussion. The results, if sustained in final analysis, would mark a rare accelerated regulatory path for therapies in slowly progressive rare muscular dystrophies, where surrogate markers and biomarker‑driven approvals can shorten timelines to patient access.