BUZZ-BridgeBio shares rise as FDA initiates priority review for dwarfism drug
路透社2026/10/06 12:17On October 6th, shares of pharmaceutical company BridgeBio Pharma (BBIO.O) rose 2.5% in pre-market trading to $67.80. The company announced that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking approval for the investigational oral drug infigratinib for the treatment of children with achondroplasia, the most common type of dwarfism. The FDA has set a target decision date of February 4, 2027. The application is based on a late-stage clinical trial that met both primary and key secondary endpoints; children treated with infigratinib experienced an adjusted annual growth velocity 1.74 centimeters greater than those given placebo. The drug also improved arm span and body proportions in children under eight years old. No serious adverse events or discontinuations related to the drug were reported. BridgeBio plans to apply for European approval in the fourth quarter of 2026. As of the close of the previous trading day, BBIO shares are down 13.5% year-to-date. (For the convenience of non-English speakers, Reuters has automated this report into several other languages. Because automated translation may contain errors or lack required context, Reuters does not guarantee the accuracy of automated translation, which is provided for readers’ convenience only. Reuters accepts no liability for any damages or losses arising from the use of automated translation.)
October 6 - ** The share price of pharmaceutical company BridgeBio Pharma (BBIO.O) rose 2.5% to $67.80 in pre-market trading
** The company announced that the U.S. Food and Drug Administration (FDA) has granted priority review to its application seeking approval for the experimental oral drug infigratinib for the treatment of children with achondroplasia (the most common type of dwarfism)
** The FDA has set February 4, 2027, as the target date for a decision
** The application is based on a late-stage clinical study that met both its primary and key secondary endpoints; children treated with infigratinib had an annual growth rate (adjusted) 1.74 cm faster than those on placebo
** The drug also improved arm span and body proportion in children under 8 years old; no serious adverse events related to the drug or treatment-related discontinuations were reported
** BridgeBio plans to apply for European approval in the fourth quarter of 2026
** As of the close of the previous trading day, BBIO shares had fallen 13.5% so far this year
(To facilitate non-native English speakers, Reuters has automatically translated its reports into several other languages. As automated translations may contain errors or lack the needed context, Reuters does not guarantee the accuracy of translated texts and provides them solely for the convenience of readers. Reuters accepts no responsibility for any damage or loss caused by the use of automated translation features.)
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