Jenn Florence, Author at Elevar Therapeutics

Elevar Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Lirafugratinib as a Treatment for Patients with Advanced/Metastatic Cholangiocarcinoma (CCA) Harboring FGFR2 Fusions or Rearrangements

September 15, 2026

Submission initiates regulatory process in European Union following U.S. submission, expanding global market presence Lirafugratinib is a highly selective, irreversible FGFR2 inhibitor differentiated from existing pan-FGFR therapies FORT LEE, N.J., Sept. 15 – Elevar Therapeutics, Inc., a majority-owned subsidiary of

Elevar Therapeutics to Share Camrelizumab/Rivoceranib Poster at International Liver Cancer Association Conference on Clinical Outcomes in Younger Age Patients with Unresectable Hepatocellular Carcinoma

September 1, 2026

317

In post hoc analysis of CARES-310 trial, combination improved mPFS versus sorafenib across age subgroups Combination also improved mOS versus sorafenib in patients <50 years and ≥50 years Elevar is sponsoring Sept. 3 welcome reception at ILCA Annual Conference Brussels,

Elevar Therapeutics Announces Three Abstracts Accepted for Presentation at ESMO Congress 2026

July 27, 2026

315

Fort Lee, N.J., July 27, 2026 – 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 cancer patients with inadequate therapeutic options, today announced the

Elevar Therapeutics Receives FDA Complete Response Letter for Combination of Rivoceranib and Camrelizumab as a First-line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

July 10, 2026

313

Fort Lee, N.J., July 10, 2026 – 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 cancer patients, today announced that the U.S. Food and

Elevar Therapeutics Announces First Patients Dosed in Phase 2 Study of Lirafugratinib Among Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

June 22, 2026

310

First patient was dosed at Samsung Medical Center in Seoul, South Korea; a second at Moffitt Cancer Center in Tampa, Florida Global multi-site study includes locations in U.S., Korea, the UK, Spain, and France Study aims to confirm lirafugratinib’s

Elevar Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment

March 30, 2026

309

FDA set a Sept. 27 PDUFA date for approval decision Lirafugratinib achieved a 46.5% ORR, in CCA patients with FGFR2 fusion and rearrangement Fort Lee, N.J., March 30 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to

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

February 2, 2026

305

FDA sets PDUFA target action date of July 23, 2026 Fort Lee, N.J., Jan. 30 – 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

Elevar Therapeutics Names Dong-Gun Kim CEO as It Focuses on Post-NDA Commercialization Strategy

January 29, 2026

305

Former CEO Dr. Bryan Kim will retain current role as CEO of Verismo Therapeutics Fort Lee, N.J., Jan. 29 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Group and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and

Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma

January 28, 2026

303

Fort Lee, N.J., Jan. 28 – 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

Elevar Therapeutics Announces Publication of CARES-310 Study Final Analysis in The Lancet Oncology

December 3, 2025

314

Phase 3 trial assessed the efficacy and safety of Elevar’s rivoceranib in combination with camrelizumab as a first-line therapy for uHCC The combination continued to show clinically meaningful survival improvement versus sorafenib, a standard first-line treatment for uHCC Elevar plans to resubmit

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

December 3, 2024

303

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

302

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

285

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

258

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

253

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

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Author: Jenn Florence

Press Releases & News

Elevar Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Lirafugratinib as a Treatment for Patients with Advanced/Metastatic Cholangiocarcinoma (CCA) Harboring FGFR2 Fusions or Rearrangements

Elevar Therapeutics to Share Camrelizumab/Rivoceranib Poster at International Liver Cancer Association Conference on Clinical Outcomes in Younger Age Patients with Unresectable Hepatocellular Carcinoma

Elevar Therapeutics Announces Three Abstracts Accepted for Presentation at ESMO Congress 2026

Elevar Therapeutics Receives FDA Complete Response Letter for Combination of Rivoceranib and Camrelizumab as a First-line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Elevar Therapeutics Announces First Patients Dosed in Phase 2 Study of Lirafugratinib Among Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

Elevar Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment

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

Elevar Therapeutics Names Dong-Gun Kim CEO as It Focuses on Post-NDA Commercialization Strategy

Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma

Elevar Therapeutics Announces Publication of CARES-310 Study Final Analysis in The Lancet Oncology

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

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

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

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

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