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
Submission initiates regulatory process in European Union following U.S. submission, expanding global market
Press Release Disclaimer: This is a press release distributed through the XPR Media network. It has not been independently verified by our newsroom.
- 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, 2026 (GLOBE NEWSWIRE) — 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 the submission of a marketing authorization application to the European Medicines Agency (EMA) for lirafugratinib as a second-line treatment for patients with advanced/metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusions or rearrangements.
The application is based on results of the Phase 1/2 ReFocus study, of which the primary endpoint is objective response rate (ORR). In advanced/metastatic FGFR2 fusion+ CCA patients after receiving a prior line of systemic therapy, lirafugratinib achieved an ORR of 46.5% as assessed by independent review committee. The median duration of response, a key secondary endpoint, was 11.8 months. Median progression-free survival was 11.3 months, while median overall survival was 22.8 months.
“Lirafugratinib is a novel drug candidate that has demonstrated meaningful clinical activity and a differentiated safety profile consistent with its high selectivity for FGFR2 and sustained inhibitory mechanism,” said Dong-Gun Kim, chief executive officer of Elevar. “We will continue to advance the regulatory processes in the United States and European Union while broadening the therapeutic potential of lirafugratinib across multiple solid tumors through our tumor-agnostic clinical development program.”
Lirafugratinib is an irreversible inhibitor that selectively targets FGFR2, differentiating it from existing pan-FGFR inhibitors that broadly inhibit FGFR1, FGFR3, and/or FGFR4 in addition to FGFR2. Consistent with its high selectivity, the rates of hyperphosphatemia and diarrhea – adverse events commonly associated with non-selective FGFR inhibitors – were 20.7% and 21.6%, respectively.
Lirafugratinib received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in 2022 and Breakthrough Therapy Designation in 2023. Elevar submitted a New Drug Application for lirafugratinib to the FDA in January 2026, and the application was granted Priority Review. The FDA is currently reviewing the application, with a Prescription Drug User Fee Act target action date of Sept. 25, 2026.
Elevar is also conducting ReFocus202, a global Phase 2 study evaluating lirafugratinib in patients with various solid tumors harboring FGFR2 fusions or rearrangements. Patient enrollment and dosing are currently underway at clinical sites globally, including in the EU, U.K., Korea and U.S. Through this program, Elevar seeks to expand the therapeutic potential of lirafugratinib beyond CCA to a broader range of solid tumors with a FGFR2 fusion or rearrangement.
About Lirafugratinib
Lirafugratinib (aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for cancer patients. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on LinkedIn and X or visit ElevarTX.com.
Forward-Looking Statements
This press release contains forward-looking statements including, without limitation, statements regarding the anticipated commercial launch, market acceptance, patient access, future development activities, regulatory obligations, commercial opportunities, and the expected benefits and potential of lirafugratinib. These forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to materially differ from those expressed or implied by such statements. Such risks and uncertainties include, among others, the timing and success of commercialization activities; manufacturing capacity and product supply; market acceptance; the availability and adequacy of reimbursement coverage; competition from existing or future therapies; safety findings; post-marketing regulatory requirements and commitments; and other risks and uncertainties affecting Elevar’s business and operations.
FDA or EMA approval does not guarantee commercial success or any particular level of market adoption, reimbursement, revenue generation, or clinical outcomes in broader patient populations. Except as required by applicable law, Elevar undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date of this press release.
Additional information regarding these and other risks and uncertainties can be found in HLB Co., Ltd.’s periodic reports, material event disclosures, and other public filings made with the Korea Exchange (“KRX”) and the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (“DART”). Readers should review those disclosures carefully, including risk factors relating to product commercialization, regulatory compliance, reimbursement, manufacturing, competition, and financial performance. All forward-looking statements contained in this press release are expressly qualified by these cautionary statements.
Media Contact: Rosemary Ostmann
RoseComm
Cell: (201) 615-7751
