LianBio To Shut BridgeBio-Partnered Bile Duct Cancer Drug Trial

LianBio LIAN reported that its partner BridgeBio Pharma Inc BBIO informed LianBio that Helsinn Healthcare SA, which holds the Truseltiq (infigratinib) New Drug Application (NDA) in the U.S., is permanently discontinuing distribution of the drug.
It also anticipates requesting the withdrawal of the NDA in the U.S. due to business reasons.
Due to the planned withdrawal of the NDA, BridgeBio informed LianBio that it intends to close the ongoing global Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA).
Consequently, LianBio is terminating activities related to the PROOF-301 trial in China and no longer plans to pursue developing and commercializing infigratinib in CCA indications in its licensed territories.
LianBio intends to continue supporting patients currently being treated with infigratinib in China under the special Named Patient Program in Hainan Province.
LianBio expects to continue the ongoing Phase 2a proof of concept trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Price Action: BBIO shares are down 7.76% at $10.58, and LIAN stock is down 2.73% at $1.78 on the last check Thursday.