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BBIO — BridgeBio Pharma News Story

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BridgeBio rises on FDA priority review for dwarfism drug

BUZZ-BridgeBio rises on FDA priority review for dwarfism drug

** Shares of drugmaker BridgeBio Pharma BBIO.O rise 2.5% to $67.80 premarket

** Co says US FDA grants priority review to its application seeking approval of experimental oral drug infigratinib for children with achondroplasia, the most common form of dwarfism

** FDA sets Feb. 4, 2027, as target date for its decision

** Application is backed by a late-stage study that met its main and key secondary goals; children treated with infigratinib grew an adjusted 1.74 cm per year faster than those given placebo

** Drug also improved arm span, as well as body proportions among children younger than eight; no serious side effects linked to the drug or treatment-related discontinuations were reported

** BridgeBio plans to seek European approval in Q4 2026

** As of last close, BBIO down 13.5% YTD


(Reporting by Kunal Das in Bengaluru)

((Kunal.Das2@thomsonreuters.com;))

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