HLB Hits the Daily Upper Price Limit at the Open on FDA Approval of LYRFIGTU [Stock Now]

[Financial News] HLB went straight to the daily upper price limit as the regular session opened following news that LYRFIGTU, its new cholangiocarcinoma treatment, had received approval from the U.S. Food and Drug Administration (FDA). As of 9:07 a.m. on the 28th, HLB was trading at 39,700 won, up 9,150 won, or 29.95%, from the previous session. The stock also opened at the upper price limit in the Nextrade (NXT) pre-market held before the regular session, as strong buying continued following the FDA approval announced during the Chuseok holiday.
Elevar Therapeutics, HLB's U.S. subsidiary, received FDA approval on the 23rd local time for LYRFIGTU as a second-line treatment for adults with unresectable, locally advanced, or metastatic cholangiocarcinoma involving FGFR2 fusions or rearrangements.
HLB said the approval marked the first case in which a Korean pharmaceutical or biotechnology company directly submitted a new drug application (NDA) for a globally developed anticancer drug to the FDA and secured approval.
In the global Phase 1 and 2 ReFocus clinical trial that supported the approval, the approved patient population recorded an objective response rate (ORR) of 45.7%, a median duration of response (mDOR) of 11.8 months, and a median progression-free survival (mPFS) of 11.3 months.
With the approval, HLB plans to launch LYRFIGTU in the U.S. market in the fourth quarter of this year. Having cleared the regulatory hurdle of FDA approval, the company's ability to expand prescriptions in actual U.S. medical settings and convert them into sales is expected to become the new benchmark for evaluation.
Meanwhile, HLB is pursuing entry into the European market for LYRFIGTU while accelerating the expansion of its pipeline. On the 14th, Elevar submitted a marketing authorization application for the cholangiocarcinoma treatment to the European Medicines Agency (EMA). It is also conducting the tumor-agnostic ReFocus202 trial for solid tumors with FGFR2 fusions or rearrangements.

[email protected] Kang Jung-mo Reporter