BridgeBio shares rise on Phase 3 FORTIFY data for BBP-418 in LGMD2I/R9
BridgeBio shares rose 2.10% to $69.41 after Phase 3 FORTIFY interim data for oral BBP-418 in LGMD2I/R9 showed broad efficacy and placebo-matched safety. The company plans a U.S. FDA filing in H1 2026.
BridgeBio Pharma stock climbed 2.10% to $69.41 on Friday, March 13, 2026, after additional interim data from the Phase 3 FORTIFY trial of oral BBP-418 in limb-girdle muscular dystrophy (LGMD2I/R9) showed broad efficacy across mobility, biomarkers, and subgroups. The safety profile matched placebo, and the company said the results reinforce plans for a U.S. FDA approval filing in the first half of 2026. BBP-418 is positioned as a potential first approved therapy for any LGMD form.
The additional interim data were presented at the MDA conference. The trial results underlined BBP-418's potential as a disease-modifying therapy for LGMD2I/R9, a condition affecting roughly 1 in 15,000-50,000 worldwide.
BridgeBio said it plans an FDA submission in H1 2026. The company also described parallel progress in infigratinib for achondroplasia, with H2 2026 filings in view.
BridgeBio, a clinical-stage biopharmaceutical company headquartered in Palo Alto, California, develops precision medicines for genetic diseases and cancers. It operates as a parent company with subsidiaries targeting monogenic diseases including LGMD and achondroplasia, while revenues remain nascent and Attrubyde is described as its first commercial product.
The article said short interest had dropped 10% to 17.49 million shares, or 14.1% of float, while Prosight Management LP disclosed selling 208,187 shares in Q3, reducing its stake by 44% to 264,500 shares valued at $13.7 million. It also said insider 10b5-1 plans listed sales of 140,000 shares.
BridgeBio's balance sheet was described as supporting near-term catalysts, though net losses persist due to pipeline investment and cash burn remains a watchpoint.