BridgeBio nabs accelerated review in U.S. for infigratinib for bile duct cancer

BridgeBio Pharma (NASDAQ:BBIO) is up 7% premarket on light volume in reaction to the FDA’s Fast Track and Orphan Drug designations for infigratinib for the first-line treatment of advanced/metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 gene fusions or translocations.

Dosing is underway in a 384-subject Phase 3 clinical trial, PROOF, with an estimated primary completion date in October 2021. The primary endpoint is progression-free survival (PFS) at month 12 compared to chemo.

https://seekingalpha.com/news/3529744-bridgebio-nabs-accelerated-review-in-u-s-for-infigratinib-for-bile-duct-cancer