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Multiple HLB stocks hit the 30% daily limit — again! An FDA inspection of the finished-drug plant for HLB's liver cancer drug rivoceranib ended with a Voluntary Action Indicated (VAI) rating, a good sign for the drug's next approval bid. HLB's U.S. unit Elevar plans to refile the new drug application (NDA) as soon as possible.

#HLB #HLBPharmaceutical #Rivoceranib #FDA #HLBStock #KoreanStocks

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00:00MULTIPLE HLB STOCKS HIT THE 30% DAILY LIMIT, AGAIN.
00:04WHAT ON EARTH SPARKED THIS RALLY?
00:06ON OCTOBER 6, HLB PHARMACEUTICAL AND HLB BIOSTEP HIT THE CAP,
00:10AND THE WHOLE GROUP SOARED.
00:12LAST MONTH, HLB'S BILE-DUCT CANCER DRUG, LIRFIGTU,
00:16BECAME THE FIRST NEW CANCER DRUG A KOREAN FIRM GOT FDA-APPROVED ON ITS OWN.
00:20THIS TIME, CHINESE PARTNER HANGRUI'S PLANT-MAKING LIVER CANCER DRUG, RIVOSERANIB,
00:25CAME THROUGH ITS FDA INSPECTION WITH A VAI,
00:28VOLUNTARY ACTION INDICATED.
00:30IT FLAGS ISSUES THE MAKER CAN FIX ITSELF, NOTHING THAT BLOCKS APPROVAL.
00:35HLB'S U.S. UNIT ELIVER SAYS IT WILL REFILE FOR APPROVAL AS SOON AS POSSIBLE.
00:39IF RIVOSERANIB FOLLOWS LIRFIGTU, KOREA GETS ITS SECOND SUCH CANCER DRUG.
00:43WILL HLB'S LIVER CANCER DRUG FINALLY WIN APPROVAL?
00:47LEAVE A COMMENT.

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