HLB’s experimental drug gains FDA fast-track review status

Corporate logo of biotechnology firm HLB / Courtesy of HLB

By Lee Kyung-min

• Published Mar 30, 2026 2:45 PM KST

Korean biotechnology firm HLB said its experimental bile duct cancer treatment has been flagged for priority review from the U.S. Food and Drug Administration, speeding up the regulatory process and paving the way for potential approval by late September.

The company said its U.S. subsidiary, Elevar Therapeutics, was notified Thursday that the FDA had accepted its new drug application for lirafugratinib, a targeted therapy for bile duct cancer patients with fibroblast growth factor receptor 2 (FGFR2) gene alterations who have received prior treatment.

The designation shortens the review period to six months from the standard 10 months, with a decision expected by Sept. 27, the company said.

Lirafugratinib is being evaluated as a second-line treatment for patients with cholangiocarcinoma, a rare and often aggressive cancer of the bile ducts. HLB said the drug demonstrated an objective response rate of 47 percent in clinical trials, compared to 36 percent for pemigatinib and 42 percent for futibatinib, both approved FGFR inhibitors.

The company also said the treatment showed a manageable safety profile, with side effects that were predictable and controllable through dose adjustments.

HLB said it plans to devote significant resources to securing regulatory approval and preparing for commercialization, citing what it described as competitive clinical data.

Kim Dong-gun, chief executive of Elevar Therapeutics, said the FDA’s decision to grant priority review and begin a full evaluation marked a pivotal moment for the company.

“This is a highly encouraging signal for our corporate value,” Kim said. “We will focus all capabilities on major milestones, including potential approval and commercialization of a liver cancer treatment by July and this bile duct cancer therapy by September.”

The company added that it is also accelerating broader clinical trials of lirafugratinib across multiple cancer types.

This article was published with the assistance of generative AI and edited by The Korea Times.