Sandoz enters global collaboration license agreement with Henlius to commercialize ipilimumab in multiple indications May 6, 2025
Ph 1 study targeting GPC3 with 225Ac-GPC3 (BAY 3547926) in patients with advanced HCC initiated May 6, 2025
Patient Enrollment completed in Ph 3 Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent HCC March 11, 2025
European Commission Approves Opdivo + Yervoy for the 1L Treatment of Adult Patients with Unresectable or Advanced HCC March 11, 2025
Fast Track Designation granted from the U.S. FDA for Amezalpat to Treat Patients with HCC February 19, 2025
ASCO GI 2025: Final Ph 2 Clinical Casdozokitug Combination Data in Patients with Metastatic HCC Presented January 28, 2025
FDA Study May Proceed Letter received for Pivotal Ph 3 Trial of Amezalpat Combination Therapy for the Treatment of 1L HCC November 19, 2024
Tempest Announces Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into 1L HCC Pivotal Trial October 15, 2024
NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis October 1, 2024
GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 + KEYTRUDA in Patients with IO-Resistant HCC, Melanoma, and RCC September 3, 2024
FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
First Patient Dosed in Ph 2 Trial of HLX53 + Serplulimab + HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic HCC Patients August 22, 2024
Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat 1L HCC Announced August 22, 2024
Supplemental NDA of Opdivo – Yervoy Combo submitted in Japan to Expand the Use for Unresectable HCC August 13, 2024
EMA validated Type II Application for Opdivo plus Yervoy for 1L Treatment of Unresectable or Advanced HCC July 23, 2024
Plans for Near-Term Resubmission of NDA for 1L Treatment Option for Unresectable HCC Following Type A FDA Meeting Reported July 17, 2024
New Survival Data for Amezalpat (TPST-1120) in 1L HCC Study Demonstrated a Six-Month Improvement over Control Arm June 25, 2024
Ph 3 pivotal Namodenoson HCC study recruiting in medical centers in Europe, Israel and the US June 11, 2024
Positive Ph 1/2 Data for GT-30 Trial of Personalized Therapeutic Cancer Vaccine Announced May 15, 2024
