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BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for ...
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Fusion42 · 6 October 2026 · Fusion42 review
BridgeBio's New Drug Application (NDA) for oral infigratinib to treat children with achondroplasia has been accepted by the FDA for priority review, with a PDUFA target action date of February 4, 2027. The Phase 3 PROPEL 3 study showed significant efficacy in growth and body proportionality improvements, positioning infigratinib as the first oral therapy option for this condition.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
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You need to prepare for the launch of the first oral treatment for achondroplasia, a rare genetic condition, as FDA priority review fast-tracks market entry. This opens a new treatment category that could reshape patient care and competition in rare bone disorder therapies.
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2 sources · 6 Oct 2026
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