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BridgeBio Pharma Receives FDA Acceptance For Filing Its New Drug Application With Priority Review For Oral Infigratinib To Treat Achondroplasia

Benzinga·10/06/2026 11:34:02
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BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) with Priority Review for oral infigratinib for the treatment of children with achondroplasia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.