Catalyst Biosciences Receives Orphan Designation from the European Commission for Marzeptacog Alfa (Activated)
Catalyst has also completed dosing in the Phase 2 portion of the Phase 2/3 subcutaneous trial of MarzAA for the treatment of hemophilia A or B with inhibitors. Nine subjects successfully completed dosing and top-line results will be presented in the third quarter of 2019.
“Orphan designation is another important acknowledgement of the significant benefits of subcutaneous MarzAA and will complement our orphan drug designation already granted in the U.S. by the
About 30 million people living in the
Catalyst is a clinical-stage biopharmaceutical company 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, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statement of historical facts, including, but not limited to, statements about the potential for MarzAA to treat patients with hemophilia B with or without inhibitors, and plans to announce top-line results for the Phase 2/3 trial in the third quarter of 2019 and to initiate a Phase 3 MarzAA registration study in 2020 are forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including, but not limited to, the risk that ongoing or planned trials may be delayed and may not have satisfactory outcomes, that such trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of the Company’s products, including the generation of antibodies, and other risks described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
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Source: Catalyst Biosciences, Inc.