Elevar Therapeutics Wins FDA Conditional Acceptance for LYRFIGTU Brand Name

Elevar Therapeutics Inc., a subsidiary of South Korea's HLB Co. Ltd. (028300.KQ), said on Sept. 22, 2026, that the U.S. Food and Drug Administration granted conditional acceptance of LYRFIGTU as the brand name for lirafugratinib. The drug candidate is currently under FDA Priority Review as a treatment for FGFR2-driven cancers, according to the company. Conditional acceptance of a proprietary name does not constitute regulatory approval, but it clears a labeling step as the company advances the therapy through the agency's review process. Elevar did not disclose an expected FDA action date or additional trial data.