HLB closed at the upper price limit on the first trading day reflecting news of the U.S. Food and Drug Administration's (FDA) approval of its bile duct cancer drug. The FDA approval, which came during the Chuseok holiday period, was reflected all at once in the stock price on the 28th, and market attention is now shifting to whether the upward trend will continue in Tuesday's session on the 29th, immediately following the limit-up close.

■ Surges 9,150 Won (29.95%) to Close at 39,700 Won

On the 28th, HLB finished trading at 39,700 won, up 9,150 won (29.95%) from the previous trading day. The opening, high, and low prices all formed at 39,700 won, maintaining the price limit throughout the regular session. The approval news was delivered while the domestic stock market was closed for the Chuseok holiday, and when trading resumed on the 28th, investors' buying interest concentrated. HLB also rose to the price limit in the NXT premarket and maintained the upper limit in the regular session.

■ Catalyst: FDA Approval of Elevare Therapeutics' Bile Duct Cancer Drug 'Refigo'

The direct catalyst that lifted the stock price was the FDA approval of 'Refigo (LYRFIGTU, ingredient name lirafugratinib),' a bile duct cancer drug from U.S. subsidiary Elevare Therapeutics. On the 23rd, the FDA approved Refigo as a treatment for adult patients with previously treated, unresectable, locally advanced, or metastatic bile duct cancer harboring FGFR2 gene fusions or other rearrangements. According to the clinical results released by the FDA, the objective response rate (ORR) was 46%, and the median duration of response was 11.8 months.

■ Tuesday's Session: A Stage for 'Supply-Demand Confirmation' After the Limit-Up

As HLB stated, this FDA approval can be seen as a significant milestone in the company's long-pursued new drug development business. In particular, with an actual approval secured in the U.S. market, future commercialization schedules and sales strategies have become new variables that will move the stock price.

However, in Tuesday's session on the 29th, the supply-demand dynamics formed after the limit-up, rather than the FDA approval itself, may become more important. On the 28th, the approval news that had accumulated during the market closure was reflected all at once, but from the next trading day onward, remaining buy orders at the upper limit, changes in trading volume, profit-taking volume, and supply-demand from foreign and institutional investors could increase stock price volatility.

The U.S. launch schedule for Refigo is also a point to watch in the market. HLB has stated its plan to pursue the U.S. market launch of Refigo along with European approval and expansion of indications. Having passed the first gateway of FDA approval, the actual expansion of prescriptions and the timing of revenue generation are expected to become mid- to long-term evaluation factors.

Therefore, for HLB's stock price on Tuesday, rather than simply whether it rises further, it is necessary to check: ▲at what price level trading forms if the upper limit is released, ▲how much trading volume increases, and ▲whether the strength of related group stocks continues.

[This article is an informational piece based on publicly available FDA materials and market data, and does not guarantee the rise or fall of any specific stock or recommend buying or selling. Stock prices can fluctuate significantly depending on corporate performance, supply-demand conditions, and market environments, and responsibility for losses from investment lies with the investor. Some sentences and data compilation utilized AI, and the final content is reviewed by the editor.]