HLB and its affiliates have all weakened after the U.S. approval review period for rivoceranib, a liver cancer drug candidate, was set at six months, four months longer than expected. HLB shares slid more than 19% early in the session.
On the 4th, HLB said it had received notice that the main review had begun for the new drug application (NDA) for rivoceranib and a hepatocellular carcinoma treatment, which its U.S. subsidiary Elevar Therapeutics resubmitted to the U.S. Food and Drug Administration (FDA). The FDA classified this submission as Class 2 and set the review target date at April 9, 2027. A Class 2 review runs for six months from the resubmission date, longer than the two months for Class 1. HLB had expected the review to be completed within this year, having anticipated a Class 1 classification.
As of 9:32 a.m. that day on the KOSDAQ market, HLB was trading at 32,950 won, down 7,750 won (19.04%) from the previous session.
At the same time, HLB Bio Step was at 5,330 won, down 1,240 won (18.87%), and HLB Pharmaceutical was at 8,600 won, down 1,930 won (18.33%). HLB Life Science fell 460 won (13.73%) to 2,890 won, and HLB Therapeutics fell 335 won (13.01%) to 2,240 won. HLB Panagene (1,153 won) and HLB Genex (2,155 won) also fell 144 won (11.10%) and 265 won (10.95%), respectively.