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Investing.com -- BridgeBio Pharma (NASDAQ:BBIO) stock rose 15% after reporting positive Phase 3 results for its small molecule BBP-418 in the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).
The company announced that all primary and secondary interim analysis endpoints in the FORTIFY Phase 3 study were successfully achieved, with a well-tolerated safety profile. The primary endpoint showed glycosylated αDG significantly increased by 1.8x from baseline at 3 months, while serum CK, a marker of muscle damage, was reduced by 82%.
Importantly, BBP-418 treated individuals demonstrated statistically significant improvements at 12 months in key clinical measures including ambulatory function and pulmonary function. The drug improved walking speed by 0.14 m/s from baseline and 0.27 m/s versus placebo, while lung function increased by approximately 3% predicted volume from baseline.
"We reiterate our OP on top-pick BBIO on the heels of BBP-418’s interim Ph3 data that is a blowout best-case outcome," commented Evercore ISI analyst Cory Kasimov, who raised his price target on BridgeBio to $90 from $75 while maintaining an Outperform rating.
BridgeBio intends to engage with the FDA later this year and plans to file a New Drug Application in the first half of 2026. The drug has previously received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA.
LGMD2I/R9 is a progressive muscular dystrophy that can lead to loss of ambulation and need for respiratory support. Currently, there are no approved specific treatments for the condition.
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