Key points
- HLB's US unit wins FDA approval for a cancer drug
- HLB claims a first for a Korean drug company
- Seoul trades the news Monday, after the holiday
HLB (028300) has secured US approval for a bile duct cancer drug through its American subsidiary, Elevar Therapeutics. The US Food and Drug Administration approved Lyrfigtu (lirafugratinib) on September 23, according to Elevar's release. Seoul's market was closed for the Chuseok holiday from September 24, so Monday is the first session where HLB shares can trade on the news.
Lyrfigtu is approved for adults with previously treated, advanced bile duct cancer that cannot be removed by surgery or has spread, and whose tumors have an FGFR2 gene fusion or other rearrangement. About 8,000 people in the US are newly diagnosed with bile duct cancer each year, Elevar's release says, citing the American Cancer Society.
In the trial behind the approval, tumors shrank in 46 percent of the 116 patients, according to an independent review. Those responses lasted a median 11.8 months, the FDA said in its approval notice. The drug carries warnings for eye problems and high phosphate levels in the blood, among others.
The medical name for bile duct cancer is cholangiocarcinoma, or CCA. "The FDA approval of Lyrfigtu introduces a vital second-line treatment option for patients living with CCA and their families," said Dong-Gun Kim, Elevar's chief executive officer.
Not the drug HLB investors were waiting for
For years, HLB has also sought FDA approval for a separate liver cancer treatment. That treatment combines HLB's rivoceranib with camrelizumab, an immunotherapy from China's Jiangsu Hengrui Pharmaceuticals (항서제약). The FDA answered with a complete response letter, a notice that an application can't be approved in its current form, in May 2024, in March 2025, and again this July, Maeil Business (매일경제) reported.
Elevar licensed lirafugratinib from US company Relay Therapeutics in 2024 and holds the rights to develop and sell it worldwide.
According to HLB, it's the first time a Korean drug company has filed a new drug application for a global cancer drug with the FDA itself and won approval. When Yuhan Corporation (유한양행) won US approval for Lazcluze, the application came from Johnson & Johnson, which had licensed the drug from Yuhan, the newspaper noted.
What the stock did before the holiday
HLB closed at 31,050 won ($22.79) on September 23, the last session before the holiday. The stock ended 2025 at 50,800 won ($37.28), so it's down 39 percent this year by our arithmetic. HLB was once the third-largest company on the Kosdaq by market value, and its shares were above 110,000 won ($80.73) in March 2024, Maeil Business reported.
The biggest fall came in July. After the third letter, HLB shares dropped by the maximum 30 percent Korea allows in one day, two sessions in a row. By Naver Finance data, they went from 52,200 won ($38.31) on July 9 to 25,650 won ($18.83) on July 13, a 51 percent loss in two sessions. They've recovered 21 percent since then. The shares rose 11.17 percent on August 4, during a Kosdaq rally led by biotech names.
Elevar plans to launch Lyrfigtu in the US in the fourth quarter. The company submitted an application to the European Medicines Agency on September 15. Elevar is also testing the drug in other solid tumors with FGFR2 changes, according to Maeil Business. The release gives no price for Lyrfigtu and no sales forecast.
Won figures are converted at 1,362.50 won to the dollar, the Yahoo Finance rate on September 23, 2026.
