RFL - Cornerstone Pharmaceuticals' CPI-613 gets orphan drug status for biliary tract cancer in EU

The European Medicines Agency (EMA) granted orphan drug designation to Cornerstone Pharmaceuticals' CPI-613 (devimistat) to treat advanced unresectable biliary tract cancer. Earlier in May, Rafael Pharmaceuticals, a part of Rafael Holdings (NYSE:RFL), had changed its name to Cornerstone Pharmaceuticals. The company said the orphan drug status is the fourth granted for devimistat by the EMA, after existing designations for Burkitt's lymphoma, pancreatic cancer and acute myeloid leukemia. The U.S. Food and Drug Administration had granted orphan drug designation to devimistat in seven indications, including in biliary tract cancer.

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Cornerstone Pharmaceuticals' CPI-613 gets orphan drug status for biliary tract cancer in EU