[Edaily Reporter Kim Kyung-eun ] HLB INC. stocks are trading higher across the board in early trading on the 24th. This is driven by rising expectations for an approval decision in September, following the conclusion of late-stage review discussions with the U.S. Food and Drug Administration (FDA) regarding “Lirapugratinib,” a treatment for bile duct cancer.

According to MP Doctor, as of 9:13 a.m. today, HLBbioStep(278650)rose 541 won (29.91%) from the previous trading day, hitting the daily price limit.

In addition, HLB PHARMACEUTICAL(047920)(27.39%), HLB Life Science(067630)(25.43%), HLB PANAGENE(046210)(22.53%), HLB Therapeutics(115450)(22.12%), HLB GLOBAL Co., Ltd.(003580)(19.82%), GenoFocus, Inc.(187420)(18.95%), and ANYGEN CO., LTD.(196300)(14.93%) were all trading higher.

HLB INC. announced today that it had successfully concluded the “Late-Cycle Meeting”—the final stage of the approval review process for lirapugratinib—without any significant issues. Since there were no major disagreements during the review process, expectations are high for an approval decision this coming September.

HLB Therapeutics, HLB’s U.S. subsidiary, held a Late-Cycle Meeting with the FDA on the 23rd (local time) to discuss Post-Marketing Requirements (PMR) and Post-Marketing Commitments (PMC).

HLB INC. stated, “To date, there have been no significant disagreements with the FDA regarding the progress of the review,” adding, “No new review issues that could affect approval have been raised.”

A late-cycle meeting is an official procedure conducted during the final stage of the FDA’s new drug approval review. It serves to conduct a final review of key issues during the review process while simultaneously coordinating product labeling and post-marketing safety management plans in advance, based on the assumption that approval will be granted.

Lirapugratinib is an oral, small-molecule targeted anticancer drug designed to selectively inhibit FGFR2. It is being developed for patients with cholangiocarcinoma harboring FGFR2 gene mutations. This candidate drug received Orphan Drug Designation (ODD) from the FDA in 2022 and was designated as a Breakthrough Therapy (BTD) in 2023. The FDA’s Prescribed Date for Action (PDUFA Date) is September 25.

Kim Dong-geon, CEO of Eleva, stated, “This late-cycle meeting confirmed that the approval review for lirapugratinib has entered its final stages.” He added, “As there have been no significant disagreements with the FDA regarding the review to date, we will do our utmost to proceed smoothly with the subsequent procedures to secure an approval decision in September.”