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 ...

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 ...

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 (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 ...

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 ...

- 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 ...