08:03 AM EDT, 10/27/2025 (MT Newswires) -- BridgeBio Pharma ( BBIO ) said Monday its phase 3 study of investigational oral therapy BBP-418 in patients with limb-girdle muscular dystrophy type 2I/R9 showed "clinically meaningful improvements" in motor and pulmonary function.

The study achieved all primary and secondary interim analysis endpoints with a well-tolerated safety profile, BridgeBio said. The primary interim analysis endpoint, glycosated aDG, increased by 1.8 times at three months, and the improvements were sustained at 12 months, the company said.

BridgeBio said it plans to engage with the US Food and Drug Administration to discuss the data and the submission of a new drug application for BBP-418 in H1 of 2026.

BridgeBio shares were more than 10% higher in premarket trading.