Wire · operational-macro
FDA Grants Priority Review to BridgeBio's Oral Infigratinib for Pediatric Achondroplasia
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 14 October 2026 · Fusion42 review
The FDA has granted Priority Review to BridgeBio's New Drug Application for oral infigratinib to treat pediatric achondroplasia, potentially cutting the review time to six months. This oral treatment offers a once-daily alternative to the currently approved daily injection and is based on positive Phase 3 trial results showing significant height gains in children.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 6 Oct 2026 and 14 Oct 2026.
◆ ◆ The Wire takeaway
Your biotech startup needs to note that the FDA's prioritisation of oral treatments over injections signals growing regulatory preference that could smooth market entry for oral drug innovators. The six-month priority review means you should prepare for accelerated timelines and market shifts triggered by oral formulations replacing injectables in paediatric care.
◆ Coverage
3 sources · first reported 6 Oct 2026 · latest 14 Oct 2026
◆ Related on Wire
◆ Topics