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BridgeBio Says Interim Analysis of BBP-418 Showed Individuals Reaching Normal Levels on Limb-Girdle Muscular Dystrophy Markers

BridgeBio Says Interim Analysis of BBP-418 Showed Individuals Reaching Normal Levels on Limb-Girdle Muscular Dystrophy Markers

MT newswireMT newswire2026/10/05 12:41

08:41 AM EDT, 10/05/2026 (MT Newswires) -- BridgeBio Pharma (BBIO) said Monday that new exploratory cardiac data from the 12-month interim analysis of Fortify phase 3 study of oral BBP-418 showed individuals with limb-girdle muscular dystrophy type 2I/R9 reaching normal or near-normal levels on disease markers. Data demonstrated that all participants treated with BBP-418 returned to the normal range for HS troponin l, a blood test used to detect injury to heart muscle, by month 12, compared with 40% for the placebo arm, the company said. Additionally, 54% of participants treated with BBP-418 had stable or improved left ventricular ejection fraction, a measure of how much blood is being pushed out by the heart's main chamber with each beat, at month 12 versus 25% for those on placebo, BridgeBio Pharma said. BBP-418 is currently under the US Food and Drug Administration's priority review with a Prescription Drug User Fee Act target action date of Nov. 27, according to a statement.

08:41 AM EDT, 10/05/2026 (MT Newswires) -- BridgeBio Pharma (BBIO) said Monday that new exploratory cardiac data from the 12-month interim analysis of Fortify phase 3 study of oral BBP-418 showed individuals with limb-girdle muscular dystrophy type 2I/R9 reaching normal or near-normal levels on disease markers. Data demonstrated that all participants treated with BBP-418 returned to the normal range for HS troponin l, a blood test used to detect injury to heart muscle, by month 12, compared with 40% for the placebo arm, the company said. Additionally, 54% of participants treated with BBP-418 had stable or improved left ventricular ejection fraction, a measure of how much blood is being pushed out by the heart's main chamber with each beat, at month 12 versus 25% for those on placebo, BridgeBio Pharma said. BBP-418 is currently under the US Food and Drug Administration's priority review with a Prescription Drug User Fee Act target action date of Nov. 27, according to a statement.
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华尔街见闻•2026/10/11 06:51