BBIO Stock Soars After Experimental Drug Shows Improvement In Inherited Muscle Disorder In Late-stage Trial
- Limb-girdle muscular dystrophy type 2I/R9 patients treated with BBP-418 in a late-stage study demonstrated improvements in motor and pulmonary function at 12 months, the company said.
- BridgeBio now intends to file a new drug application for the therapy’s approval in the first half of 2026.
BridgeBio Pharma, Inc. (BBIO) on Monday announced that limb-girdle muscular dystrophy type 2I/R9 patients treated with BBP-418 in a late-stage study demonstrated improvements in motor and pulmonary function at 12 months.
Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9) is a rare, inherited disorder leading to progressive weakness and wasting of the arm and leg muscles.
BBP-418 was well-tolerated in the study with no new or unexpected safety findings observed, the company said.
The company now intends to file a new drug application for approval of the therapy in the first half of 2026. It plans to engage with the U.S. Food and Drug Administration to discuss data from its studies later this year.
BBIO shares traded 11% higher in the pre-market session at the time of writing.
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