Scientific Advisory Board formed with internationally recognized liver and biliary tract cancer physicians to support the advancement of solid tumor pipeline programs Elevar plans for major 2025 oncology regulatory milestones - March 2025 PDUFA date and launch preparation for unresectable
Post-hoc analysis on survival outcomes for camrelizumab plus rivoceranib in patients with viral and non-viral hepatocellular carcinoma (HCC) demonstrated clinically meaningful overall survival and progression-free survival benefit for patients with hepatitis B or C viral infection HCC or non-viral
Global licensing agreement grants Elevar Therapeutics worldwide rights to develop and commercialize lirafugratinib (RLY-4008) Lirafugratinib is a potential best-in-class FGFR2 inhibitor that has shown differentiated efficacy in FGFR2-driven cholangiocarcinoma and demonstrated durable responses across multiple other types of FGFR2-altered solid tumors Relay
FDA sets a PDUFA target action date of March 20, 2025 Resubmission is supported by the final survival analysis of CARES-310 study, presented at ASCO 2024 FORT LEE, NEW JERSEY, Oct. 21, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of
FORT LEE, NEW JERSEY, Sept. 23, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug
FORT LEE, NEW JERSEY, Sept. 12, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the presentation of three posters at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Sept. 13-17. “The results
FORT LEE, NEW JERSEY, Aug. 1, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the European Medicines Agency (EMA) granted Orphan Medicinal Product Designation for rivoceranib in combination with camrelizumab as a first-line treatment
FDA confirmed resubmission can occur without delay FDA confirmed additional GMP and/or BIMO inspections may occur after resubmission Elevar plans to resubmit as soon as possible FORT LEE, NEW JERSEY, July 9, 2024 – Elevar Therapeutics, Inc. (Elevar), a
Phase 3 CARES-310 study found combination of camrelizumab and rivoceranib continued to show sustained long-term survival compared with sorafenib as a first-line treatment for uHCC Final analysis reported the longest median overall survival for any treatment in a global
A post hoc analysis found the efficacy of camrelizumab plus rivoceranib was superior to sorafenib regardless of baseline liver function as measured by both albumin-bilirubin grade and Child-Pugh class Another analysis, of patient-reported outcomes during CARES-310, demonstrated the combination
