Tovecimig Demonstrates Statistically Significant Benefit in COMPANION-002 Ph 2/3 Study in Patients with Biliary Tract Cancer April 28, 2026
Dose expansion in clinical study of spevatamig + chemo for treatment of biliary tract cancer April 28, 2026
Supplemental BLA submitted to FDA for BIZENGRI® (zenocutuzumab-zbco) in NRG1 Fusion Positive Cholangiocarcinoma; Included in updated NCCN Guidelines April 21, 2026
FDA Accepts Priority Review of NDA for Lirafugratinib as 2L Cholangiocarcinoma Treatment April 7, 2026
Zenocutuzumab‑zbco Receives FDA Orphan Drug Designation for Treatment of Cholangiocarcinoma February 9, 2026
Continued Zenocutuzumab Treatment Beyond Progression Shows Benefit in Patients with NRG1+ Pancreatic Cancer and Cholangiocarcinoma from the eNRGy Trial January 18, 2026
Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma October 29, 2025
Data from Ongoing Dose Escalation of BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma presented July 8, 2025
EC granted conditional marketing authorization for Ziihera® (zanidatamab) monotherapy for unresectable locally advanced or metastatic previously treated HER2-positive biliary tract cancer July 8, 2025
Tovecimig (CTX-009) Meets Primary Endpoint in Ph 2/3 Study in Patients with Biliary Tract Cancer April 8, 2025
Enrollment Completed in Ph 2 Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China March 11, 2025
Relay Therapeutics & Elevar Therapeutics Announce Exclusive Global Licensing Agreement for Lirafugratinib in FGFR2-Driven Cholangiocarcinoma and Other Solid Tumors December 10, 2024
FDA Approves Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer November 26, 2024
First Patient Enrolled in Ph 3 Trial of Ivonescimab Combination as 1L Therapy for Biliary Tract Tumors, Compared to Durvalumab November 5, 2024
Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma September 10, 2024
WITHDRAWN: FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma May 21, 2024
Imfinzi + chemo doubled OS rate at 3 years for patients with advanced biliary tract cancer in TOPAZ-1 Ph 3 trial April 23, 2024
Zanidatamab BLA for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer initiated April 8, 2024
Global Ph 3 Clinical Trial for Cholangiocarcinoma Authorized in the EU and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by EMA March 19, 2024
