QualityStocksNewsBreak – EMA Committee for Orphan Medicinal Products Recommends Designation for Catalyst Biosciences, Inc.’s (NASDAQ: CBIO) Factor IX
Shares of Catalyst Biosciences (NASDAQ: CBIO) are 15% higher this morning on news that a positive opinion recommending orphan medicinal product designation has been issued by the European Medicines Agency Committee (EMA) for Orphan Medicinal Products (COMP) regarding Catalyst’s CB 2679d for the treatment of hemophilia B. The clinical-stage biopharmaceutical company’s highly potent next-generation coagulation Factor IX variant demonstrated potential to normalize human Factor IX levels with a daily subcutaneous injection in preclinical studies. Currently approved therapies rely on numerous intravenous infusions. “Obtaining orphan drug designation is an important part of our regulatory approval strategy for CB 2679d, and the…