News Archives - Elevar Therapeutics

Elevar Therapeutics and Relay Therapeutics Announce Exclusive Global Licensing Agreement for Lirafugratinib in FGFR2-Driven Cholangiocarcinoma and Other Solid Tumors

December 3, 2024

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

Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma

October 21, 2024

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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

Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis

September 23, 2024

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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

Elevar Therapeutics Reports Advances in HCC and Other Oncology Clinical Programs for Rivoceranib Plus Camrelizumab at the European Society for Medical Oncology Congress 2024

September 12, 2024

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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

Elevar Therapeutics Granted Orphan Medicinal Product Designation by the European Medicines Agency for First-Line Systemic Therapy for Unresectable Hepatocellular Carcinoma

August 1, 2024

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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

Elevar Therapeutics Reports Plans for Near-Term Resubmission of NDA for First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Following Type A FDA Meeting

July 9, 2024

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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

Elevar Therapeutics Reports Landmark Median Overall Survival of 23.8 Months in First-Line Treatment for Unresectable Hepatocellular Carcinoma

May 30, 2024

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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

Elevar Therapeutics To Present Two Posters From Phase 3 CARES-310 Study at 2024 ASCO Gastrointestinal Cancers Symposium

January 18, 2024

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

Elevar Therapeutics Names Brian Cunningham Vice President of Sales and Kenneth Rankin Vice President of Market Access, Strengthening Commercial Leadership in Buildup to Launch

October 23, 2023

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

Elevar Therapeutics and Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC

October 17, 2023

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

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