HLB Group stocks plunged across the board following news that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The disclosure that a CRL had been issued during the approval review process for a first-line liver cancer treatment dealt a heavy blow to investor sentiment, triggering a sell-off across the entire group.

As of the morning session on the 10th, HLB recorded a lower limit at 36,600 won. This represents a decline of 15,600 won from the previous day, with a change rate of -29.89%. The previous day's gain of 2,800 won was wiped out in a single day, with the stock falling from an intraday high of 39,800 won to the lower limit. Trading volume stood at 662,056 shares.

HLB announced that its U.S. subsidiary Elevar Therapeutics received a CRL from the FDA regarding the approval review for the combination therapy of rivoceranib and camrelizumab as a first-line liver cancer treatment. The impact of this news spread throughout HLB Group stocks.

HLB Biostep fell by 855 won to 2,005 won, recording -29.90%, while HLB Life Sciences dropped 950 won to 2,230 won, showing -29.87%. HLB Pharm also declined 3,670 won to 8,570 won, posting -29.98%. HLB Therapeutics fell 665 won to 1,565 won for -29.82%, and HLB Panagen dropped 444 won to 1,037 won, recording -29.98%. HLB Global also fell 482 won to 1,133 won, marking -29.85%. HLB Innovation slipped 3,360 won to 8,880 won for -27.45%, while HLB Genex declined 420 won to 1,488 won, showing -22.01%. HLB Pepp fell 545 won to 4,135 won, recording -11.65%.

The market analyzes that this sharp decline is not merely a correction of individual stocks, but rather a revaluation of the entire HLB Group, which has been highly sensitive to approval expectations. In particular, although the CRL is known to focus on manufacturing facility and quality control standards rather than clinical efficacy, the possibility of a delay in the approval timeline was magnified, leading to a significant short-term supply-demand shock.

HLB stated that it plans to promptly implement the corrective actions requested by the FDA and then pursue resubmission for approval. However, key variables that will determine the stock's recovery include the possibility of a future re-inspection, the speed of manufacturing facility remediation, the resubmission timeline, and additional disclosure contents.

[※ This article was written with AI assistance based on provided disclosure information and intraday market data. Stock prices and trading volumes may fluctuate in real time depending on market conditions, so investment decisions should be made carefully at one's own discretion after directly verifying the latest disclosures and market prices.]