HLB's liver cancer drug candidate, Riboceranib, is facing a delay in approval from the U.S. Food and Drug Administration (FDA), leading to a significant drop in stock prices for HLB and HLB Pharmaceuticals.
As of 8:40 a.m. on November 4, HLB shares were trading at 31,350 won, down 9,300 won (22.85%) from the previous trading day. HLB Pharmaceuticals also saw a decline, trading at 8,140 won, down 2,380 won (22.60%). The stock of HLB Pharmaceuticals fell to the price limit of 8,030 won shortly after the NXT opened, before experiencing a slight rebound.
The decline in HLB and HLB Pharmaceuticals' stock prices is attributed to the failure to secure FDA approval for the liver cancer drug candidate within the year.
On the same day, HLB announced that its U.S. subsidiary, Elevate Therapeutics, received notification from the FDA regarding the commencement of the main review for the approval application of Riboceranib, an oral vascular endothelial growth factor receptor inhibitor, in combination with the immuno-oncology drug Camrelizumab as a first-line treatment for hepatocellular carcinoma.
The FDA classified the application as Class 2 and set a target date for a decision on April 9, 2027. Class 2 is one of the classifications for FDA review of resubmission materials, with a typical review period of six months.
Previously, HLB had anticipated a Class 1 classification for this new drug during its IR day. Class 1 has a shorter review period of two months and a more limited scope than Class 2, leading to expectations for approval within the year.
As a result, the FDA's classification of Class 2 has led to disappointment among investors, who had hoped for an early approval scenario.
Regarding the resubmission for the liver cancer drug, Kim Dong-geun, CEO of Elevate Therapeutics, stated, "Through the CARES-310 study, we confirmed the potential for significant improvement in survival rates for patients with unresectable hepatocellular carcinoma using the combination of Riboceranib and Camrelizumab as first-line treatment. With the main review resuming, we will work closely with Jiangsu Hengrui Medicine to ensure thorough preparation for the FDA review."
* This article has been translated by AI.
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