#ElevarTx Archives - 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

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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

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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

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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

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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

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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

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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

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