Elevar Therapeutics Receives FDA Conditional Acceptance of LYRFIGTU as Brand Name for Lirafugratinib
In March, the FDA granted Priority Review of Lyrfigtu (lirafugratinib); PDUFA date of September 25, 2026 Lyrfigtu
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- In March, the FDA granted Priority Review of Lyrfigtu (lirafugratinib); PDUFA date of September 25, 2026
- Lyrfigtu (lirafugratinib) achieved a 46% ORR, in CCA patients with FGFR2 fusion or other rearrangement
Fort Lee, N.J., Sept. 22, 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 U.S. Food and Drug Administration (FDA) has granted conditional acceptance of LYRFIGTU™ as the brand name for lirafugratinib, which is currently under FDA Priority Review as a treatment option for patients with advanced/metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or other rearrangement.
The proposed name Lyrfigtu (pronounced leer fig tu) was developed in accordance with the FDA’s guidance on proprietary names. Final acceptance of the Lyrfigtu brand name will be established upon FDA approval of lirafugratinib. In January, the FDA accepted Elevar’s new drug application for lirafugratinib and subsequently granted Priority Review to the application and assigned a Prescription Drug User Fee Act target action date of September 25, 2026.
“The FDA’s conditional acceptance of the Lyrfigtu brand name represents another important milestone in Elevar’s effort to potentially commercialize lirafugratinib and, if approved, introduce a new therapeutic option for patients confronted with cholangiocarcinoma,” said Dong-Gun Kim, chief executive officer of Elevar. “With the PDUFA date set for later this month, we are hopeful of a positive result and highly focused on preparing for a potential launch to make the drug available to doctors and patients as quickly as possible, subject to FDA approval.”
CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. newly diagnosed each year, according to the American Cancer Society.
In the Phase 1/2 ReFocus trial (NCT04526106), lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% and a median duration of response of 11.8 months in patients with the proposed indication. Its safety profile in the clinical data is being evaluated by the FDA as part of the ongoing review process. Adverse events observed in the trial were managed through dose adjustments.
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. Lirafugratinib is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration for any indication. 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 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.
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