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 receipt of the positive COMP opinion puts us one step closer to this goal,” Catalyst president and CEO Nassim Usman, Ph.D. stated in the news release.
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About Catalyst Biosciences, Inc.
Catalyst Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. For more information, visit www.catalystbiosciences.com.
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