BridgeBio Pharma's New Drug Application for Genetic Short Stature Condition Accepted by US FDA
MT newswire2026/10/06 12:2508:25 AM EDT, 10/06/2026 (MT Newswires) -- BridgeBio Pharma (BBIO) oral version of Infigratinib's new drug application has been accepted by the US Food and Drug Administration as a treatment for children with achondroplasia, the company said Tuesday. The treatment has also been granted priority review with a target action date of Feb. 4, the company said. Achondroplasia is a genetic disorder which is the most common cause of disproportionate short stature. The FDA's acceptance was based on a phase 3 study that met its primary and key secondary endpoints, showing statistically significant improvement in both body proportionality and arm span in comparison with a placebo, the company said. BridgeBio plans to submit a marketing authorization application for achondroplasia to the European Medicines Agency in Q4 2026, it said. Shares of the company were up 2.1% in recent premarket trading.
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