BridgeBio reported positive Phase 3 results for a rare‑disease candidate and is moving to adjust its regulatory strategy to pursue a U.S. filing. The interim analysis showed statistically significant improvements on key biomarkers and clinical outcomes that the company described as strong enough to support an accelerated engagement with the FDA. BridgeBio said the data strengthen its submission package and could speed a review timeline, prompting a reassessment of earlier filing plans. Management framed the readout as a validation of the program’s mechanism and signaled meetings with regulators to align on the path to approval. Investors and peers will be monitoring the company’s next regulatory interactions and the final dataset; a successful filing and approval would mark an important commercial milestone and validate BridgeBio’s rare‑disease development approach.