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 HLB Co., Ltd., today announced
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 rivoceranib, an oral VEGF-TKI, in
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 to be presented at ESMO
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 option for Unresectable Hepatocellular Carcinoma
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 majority-owned subsidiary of HLB Co.,
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 Phase 3 trial in uHCC
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 of camrelizumab and rivoceranib was
Fort Lee, N.J., Oct. 23, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the hiring of Brian
In May, Elevar and Hengrui Pharma submitted an NDA and BLA for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC, with FDA PDUFA dates in May 2024 Fort Lee, N.J., and Princeton, N.J., Oct. 17, 2023 – Elevar Therapeutics, Inc., a
Fort Lee, New Jersey, Sept. 21, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced it will hold
