Abbisko Therapeutics' FGFR4 Inhibitor Irpagratinib Granted Orphan Drug Designation by EMA for Hepatocellular Carcinoma [TheStreet.com]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: TheStreet.com
SHANGHAI March 31, 2026 /PRNewswire/ -- 31 March 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256) announced that its independently developed, highly selective, oral small-molecule FGFR4 inhibitor irpagratinib (ABSK-011), has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of hepatocellular carcinoma (HCC) . Irpagratinib is currently being evaluated in multiple clinical studies across different regions globally. The ODD granted by the EMA is expected to strongly support the product's clinical development, regulatory filings, and commercialization in Europe. Orphan Drug Designation is a key incentive established by the EMA to facilitate the development and authorisation of medicines for rare diseases. The ODD granted to irpagratinib not only reflects regulatory recognition of its potential clinical value and need, but also provides access to a range of incentives, including eligibility for pr
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