FDA nod for bile duct cancer drug gives HLB fresh momentum

KOSDAQ-listed HLB has gained fresh momentum after the U.S. Food and Drug Administration approved Lyrfigtu (lirafugratinib), its treatment for bile duct cancer, giving the company its first foothold in the U.S. drug market after repeated regulatory setbacks for its liver cancer regimen.

The FDA on Sept. 23 approved Lyrfigtu, or lirafugratinib, for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement, HLB said Sunday.

The drug was developed by Elevar Therapeutics, HLB’s U.S. subsidiary, as a second-line treatment for the disease.

HLB said the approval marked the first time a South Korean pharmaceutical or biotechnology company had directly submitted a new drug application for a global cancer treatment to the FDA and secured approval.

By comparison, Yuhan Corp. licensed its lung cancer drug lazertinib to Johnson & Johnson, which filed the U.S. application and secured FDA approval.

HLB had previously sought FDA approval for a combination of rivoceranib and Chinese drugmaker Hengrui Pharma’s immunotherapy camrelizumab as a first-line treatment for liver cancer. The company received three complete response letters, or CRLs, in May 2024, March 2025 and July this year.

Lyrfigtu is a separate drug whose global development and commercialization rights Elevar acquired from U.S.-based Relay Therapeutics in 2024.

Elevar plans to launch Lyrfigtu in the United States in the fourth quarter. It also applied for marketing authorization from the European Medicines Agency this month and is conducting clinical trials to expand the drug’s use to other solid tumors with FGFR2 alterations.

“The FDA approval of Lyrfigtu introduces a vital second-line treatment option for patients living with cholangiocarcinoma and their families,” Elevar CEO Kim Dong-gun said.

The approval has also raised interest in whether investor sentiment toward HLB and other KOSDAQ-listed biotechnology companies will recover.

HLB, once the third-largest company on the KOSDAQ by market capitalization, fell by the daily limit for two consecutive sessions after receiving its third CRL on July 10.

Its shares, which traded above 110,000 won ($81) in March 2024, had fallen to 31,050 won at the close of after-hours trading on Sept. 23.