ABBISKO-B Shares Surge Nearly 10% on EMA Orphan Drug Designation for FGFR4 Inhibitor

Stock News
04/01

ABBISKO-B (02256) saw its shares climb over 10% during the trading session. At the time of writing, the stock was up 8.44%, trading at HK$13.11, with a turnover of HK$34.2099 million. The increase follows the company's announcement that its self-developed highly selective small-molecule FGFR4 inhibitor, ipagratinib (ABSK-011), has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC). Ipagratinib is currently undergoing clinical studies in multiple regions worldwide. The EMA’s ODD will provide significant support for the drug’s clinical development, regulatory submission, and commercialization process in Europe. Public information indicates that ipagratinib is an oral, highly selective small-molecule FGFR4 inhibitor developed independently by ABBISKO. In addition to the recent EMA ODD, the drug has previously received ODD and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA).

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