BridgeBio Pharma Meets Primary Endpoint For Achondroplasia Drug in Phase 3 Trial

MT Newswires Live06-29

BridgeBio Pharma (BBIO) disclosed late Sunday that it met the primary endpoint in a phase 3 trial of the oral drug infigratinib, for the treatment children living with achondroplasia, or bone dwarfism.

The positive results were published as an original research article in the New England Journal of Medicine, and also presented at the International Congress of Children's Bone Health conference, held in Montreal.

BridgeBio said it believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia.

BridgeBio intends to submit a new drug application (NDA) for achondroplasia to the Food and Drug Administration in Q3, and a marketing authorization application (MAA) for achondroplasia to the European Medicines Agency (EMA) in H2.

BridgeBio said it anticipates a US launch of oral infigratinib in early- to mid-2027.

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