HLB Biostep is continuing its double-digit rally in intraday trading on the 29th, following a limit-up close in the previous session. News of U.S. Food and Drug Administration (FDA) approval for HLB's bile duct cancer drug is spreading strong buying interest across the group's stocks.

As of the morning of the 29th, HLB Biostep is trading above 3,820 won, up more than 570 won from the previous session, with its gain exceeding 17%. After rising by the daily price limit the day before, the stock is continuing its strength today, drawing a rush of short-term buying.

Previously, HLB Biostep closed at 3,250 won on the 28th, up 30.00%, hitting the daily limit. On the same day, HLB also finished at 39,700 won, up 29.95%, while numerous group affiliates, including HLB Pharmaceutical and HLB Life Science, also rose by their daily price limits.

The direct trigger for the surge is the FDA approval of 'LYRFIGTU' (ingredient name: lirafugratinib), a bile duct cancer treatment developed by Elevar Therapeutics, HLB's U.S. subsidiary. HLB announced the approval on the 24th, and the news was also shared through the company's official channels and social media.

LYRFIGTU received FDA approval as a second-line treatment for bile duct cancer patients with confirmed FGFR2 fusion or rearrangement. HLB emphasized that this is a case in which a Korean pharmaceutical or biotech company directly submitted a new drug application (NDA) for a global anticancer drug to the FDA and obtained product approval.

In terms of the stock price trend, the shift in investor sentiment toward the entire HLB group is having a greater impact than HLB Biostep's own disclosures about new individual businesses. In particular, following the previous day's limit-up with today's gain of more than 17%, short-term price volatility has expanded significantly.

Future variables for the stock price include the actual U.S. launch schedule and sales performance of LYRFIGTU, as well as the business connections among HLB group affiliates. However, as the stock is surging again today after the previous day's limit-up, investors should note that the size of the gain could change quickly depending on intraday buying and selling flows.

[This article is informational material based on publicly available corporate documents, securities firm analyses, and market data. It does not guarantee the rise or fall of any specific stock or recommend buying or selling. Securities firms' target prices and earnings forecasts may change depending on market conditions, and responsibility for losses from investment lies with the investor. AI was used for some sentences and data compilation.]