SEOUL (dpa-AFX) - Tuesday, Elevar Therapeutics, Inc., a subsidiary of HLB Co., Ltd. (028300.KQ) announced that the U.S. Food and Drug Administration 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.
The conditional acceptance of Lyrfigtu brand name marks a milestone in Elevar's effort to commercialize lirafugratinib and, if approved, introduce a new therapeutic option for patients with cholangiocarcinoma.
The company added that the brand name was developed in accordance with the FDA's guidance on proprietary names and that its final acceptance will be established upon FDA approval of lirafugratinib.
Earlier this year, the agency 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.
HLS's stock closed at KRW 31,050.00, down 2.82 percent on the KOSDAQ.
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