HLB (028300.KQ), which awaits a U.S. Food and Drug Administration (FDA) approval decision, has moved to calm concerns over its recent sharp stock decline, saying "the approval process is proceeding normally."
According to the Korea Exchange, HLB shares closed Friday at 47,400 won, down 2.27% from the previous day.
As market anxiety over the FDA approval review grew, HLB issued an official statement. In a notice distributed to shareholders that day, HLB said, "The FDA approval processes for the liver cancer drug and the bile duct cancer drug are proceeding normally, and no conclusion has yet been reached." The company added, "As we have thoroughly prepared for approval over the past two years since the success of the global Phase 3 trial, we expect a positive outcome based on the data secured so far." The company explained that HLB Chairman Jin Yang-gon has recently been personally touring brokerage branches to hold investor relations (IR) sessions, an investor communication effort grounded in such confidence.
The company said, "As the FDA approval timing draws near, market volatility is rising, with short selling reaching nearly 40%," adding, "We hope investors will not be misled by unverified information beyond what the company has officially announced regarding FDA approval." It continued, "Important information that could affect investment decisions is being disclosed promptly and transparently in accordance with relevant regulations."
The company emphasized, "We are thoroughly managing the prevention of any leak of undisclosed information into the market," and "We ask shareholders to trust the company's official announcements and watch calmly."
HLB awaits the U.S. FDA's decision next month on the approval of its combination therapy of rivoceranib and camrelizumab for liver cancer. A result of the FDA review for its bile duct cancer treatment lirafugratinib is also scheduled for September.
