The FDA has cleared Abbisko Therapeutics' IND application for ABSK061, an oral FGFR2/3 inhibitor for achondroplasia, while BridgeBio reports positive Phase 3 results for its oral infigratinib in the same condition. Both companies are advancing oral therapies targeting FGFR3 overactivity in this genetic growth disorder.
The FDA has granted accelerated approval for YUVIWEL (navepegritide), the first once-weekly treatment for children with achondroplasia. Commercial availability is expected in early Q2 2026, with a Rare Pediatric Disease Priority Review Voucher granted.
BridgeBio Pharma announced positive Phase 3 topline results for infigratinib in children with achondroplasia, meeting primary and key secondary endpoints. The company plans regulatory submissions in the U.S. and Europe in the second half of 2026.
BridgeBio Pharma announced positive Phase 3 topline results for infigratinib in children with achondroplasia, meeting primary and key secondary endpoints. The company plans regulatory submissions in the U.S. and Europe in the second half of 2026.
