Bridgebio Pharma says it will seek U.S. approval of BBP-418 for LGMD2i after Phase 3 trial data showed a range of benefits for patients.

Shares of BridgeBio Pharma rose more than 15% to $62.52 in early trading, after the company reported positive top-line ...

All primary and secondary interim analysis endpoints in FORTIFY Phase 3 study successfully achieved with well-tolerated safety profile ...

On October 27, 2025, BridgeBio Pharma announced positive topline results from its pivotal Phase 3 FORTIFY study for BBP-418 in individuals with limb-girdle muscular dystrophy type 2I/R9, achieving all ...

(RTTNews) - BridgeBio Pharma, Inc. (BBIO) announced on Tuesday that the FDA has granted Rare Pediatric Disease Designation for BBP-418 for the treatment of Limb-girdle Muscular Dystrophy Type 2I/R9 ...

novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG ...

BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on ...

Impressive data from an interim readout of Bridgebio Pharma Inc.’s BBP-418 in limb-girdle muscular dystrophy type 2I/R9 has the company prepping to meet with the U.S. FDA to discuss plans for the ...

ML Bio Solutions has initiated a Phase 1 clinical trial of BBP-418 in healthy volunteers ML Bio Solutions’ sponsored lead-in study is enrolling patients with LGMD2i across twelve sites in the U.S. and ...

BridgeBio (BBIO) held an investor event last week focused on BBP-418, the company’s candidate for the treatment of Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), a rare muscular disease with ...

- Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025 - BridgeBio believes there is an opportunity to pursue Accelerated Approval in the ...