BridgeBio reported a positive interim Phase III readout for BBP‑418 in limb‑girdle muscular dystrophy 2I/R9, meeting pre‑specified efficacy thresholds and prompting plans to meet the FDA to discuss regulatory strategy. Company executives described the result as a potential pathway to an NDA submission and signaled intent to pursue approval timelines contingent on final data. The outcome accelerates BridgeBio’s rare‑disease agenda and shifts near‑term priorities to full dataset analysis, manufacturing scale‑up and FDA engagement. Payers and patient groups will be key stakeholders as the company prepares for potential commercialization if regulators accept the efficacy and safety package.