BridgeBio reports infigratinib Phase 3 data

• BridgeBio Pharma reported exploratory Phase 3 PROPEL 3 data showing infigratinib improved trends in sleep apnea, ear infections, and body composition in children with achondroplasia.
• The company reported lower increases in apnea-hypopnea index and reduced annualized otitis media rates compared with placebo after 52 weeks.
• BridgeBio submitted a New Drug Application to the FDA and plans a potential U.S. launch in mid-2027.

BridgeBio Pharma (NASDAQ:BBIO) reported exploratory Phase 3 PROPEL 3 data showing 52 weeks of oral infigratinib treatment produced favorable trends versus placebo in children with achondroplasia.

The study evaluated measures including sleep apnea, ear infections, and body composition after treatment with infigratinib compared with placebo.

BridgeBio reported that mean total apnea-hypopnea index increased 10.4% with infigratinib compared with 49.2% with placebo, while annualized otitis media rates were 38% lower with infigratinib versus placebo.

Across up to three years of PROPEL treatment, BridgeBio reported height Z-score improvement of +0.92 standard deviations and an upper-to-lower body ratio improvement of -0.15, with no new safety signals identified.

BridgeBio Pharma develops medicines for genetic diseases and other conditions, including investigational therapies targeting rare diseases such as achondroplasia.