[E-Daily Reporter kyoungeun kim ] HLB INC.’s new liver cancer drug “Riboceranib” hit the daily price limit down after once again failing to gain approval from the U.S. Food and Drug Administration (FDA).
According to MP Doctor, as of 10:21 a.m. on the 10th, HLB INC.(028300)was trading at 36,600 won, down 15,600 won (29.89%) from the previous day.
HLB INC.’s sharp decline today is believed to be due to an announcement that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA).
HLB Life Science’s U.S. subsidiary, Eleva Therapeutics, announced today that it received a CRL from the FDA on the 9th (local time) regarding its first-line treatment for liver cancer (combination therapy of riboceranib and camrelizumab). The FDA notified the company that it had identified deficiencies at the facility during a Current Good Manufacturing Practice (CGMP) inspection.
According to the FDA’s findings, a re-inspection by the FDA may be necessary for the facility to achieve compliance with CGMP, and the issues identified during the inspection may not be directly related to Eleva Therapeutics’ application.
Eleva Therapeutics explained that it plans to promptly address the corrective actions and proceed with a re-approval application to the FDA.