HLB is experiencing strong gains in early trading due to expectations surrounding FDA approval for its cholangiocarcinoma treatment.
As of 9:30 a.m. on July 24, HLB shares were trading at 32,650 won, up 2,650 won (8.83%) from the previous trading day.
The company announced that its U.S. subsidiary, Elevate Therapeutics, successfully completed a late-cycle meeting with the FDA regarding the approval review of the FGFR2-targeted cancer drug, liraglutide, without any significant issues. This meeting is part of the final stages of the approval process, where remaining concerns are addressed, and labeling and post-marketing plans are coordinated. HLB stated that there have been no significant disagreements with the FDA during the review process, and no new review issues that could affect approval have been raised.
The pre-approval inspection status of the manufacturing facilities for both the active pharmaceutical ingredient and the finished product was not specifically mentioned in this meeting. Liraglutide is an oral targeted cancer drug that selectively inhibits FGFR2. It was designated as an orphan drug by the FDA in 2022, received breakthrough therapy designation in 2023, and was selected for priority review this year. The FDA's decision on approval is expected by September 25.
Dong-geun Kim, CEO of Elevate, stated, "This meeting confirmed that the approval review for liraglutide is in its final stages. Since there have been no significant disagreements with the FDA so far, we will ensure that subsequent procedures are completed smoothly ahead of the approval decision in September."
Recently, HLB's stock price has shown significant volatility due to new drug approval issues. On July 10, the company’s liver cancer drug, ribociclib, received a Complete Response Letter (CRL) from the FDA, leading to two consecutive days of trading at the lower limit. However, following news that concerns regarding the manufacturing facilities had largely been resolved, the stock rebounded to the upper limit on July 15.
Additionally, HLB Group executives have been actively buying back shares, emphasizing their commitment to responsible management. Chairman Jin Yang-gon has purchased over 1.1 million shares of affiliate stocks in 50 transactions this year, and other affiliate representatives have also been buying back shares. HLB stated, "The voluntary share purchases by affiliate executives demonstrate our commitment to strengthening responsible management and enhancing corporate and shareholder value, unaffected by short-term market fluctuations."
* This article has been translated by AI.
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