BridgeBio reported interim results from the Phase 3 FORTIFY trial of oral BBP-418 in limb-girdle muscular dystrophy type 2I/R9, which were presented in a late-breaking oral presentation at the MDA Clinical and Scientific Conference. In the interim analysis, participants on BBP-418 showed a reduction in serum creatine kinase, with 60% reaching levels within 2x the upper limit of normal at 12 months. The 100-meter timed test separated from placebo as early as three months, and at 12 months the BBP-418 group completed the test about 31 seconds faster than placebo. Safety findings showed treatment-emergent adverse events in 93% of the BBP-418 arm and 100% of the placebo arm, with grade 3 or higher events occurring in 5% of each group. BridgeBio said it plans to submit a U.S. NDA for traditional approval in the first half of 2026, with a U.S. launch anticipated in late 2026 or early 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BridgeBio Pharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603111400PRIMZONEFULLFEED9670237) on March 11, 2026, and is solely responsible for the information contained therein.