|Allovir Inc., of Cambridge, Mass.||Viralym-M (ALVR-105)||Allogeneic, off-the-shelf, multivirus-specific T-cell therapy||Infection||EMA granted PRIME designation for treating serious infections with BK virus, cytomegalovirus, human herpes virus-6, Epstein-Barr virus and/or adenovirus in allogeneic hematopoietic stem cell transplantation recipients|
|Astex Pharmaceuticals Inc., of Pleasanton, Calif., a subsidiary of Otsuka Pharmaceutical Co. Ltd.||Oral C-DEC (cedazuridine and decitabine)||Fixed-dose combination of cytidine deaminase inhibitor and hypomethylating agent||Myelodysplastic syndromes||FDA accepted for priority review the NDA seeking approval for use in previously untreated patients with intermediate- and high-risk disease, including chronic myelomonocytic leukemia|
|Fibrogen Inc., of San Francisco||Roxadustat||Oral, small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor||Anemia of chronic kidney disease||FDA completed its filing review of NDA seeking approval for use in both nondialysis-dependent and dialysis-dependent patients and set PDUFA date of Dec. 20, 2020|
|Prevail Therapeutics Inc., of New York||PR-001||AAV-based gene therapy||Gaucher disease||FDA granted orphan designation; agency also granted rare pediatric disease designation for neuronopathic Gaucher disease|
For more information about individual companies and/or products, see Cortellis.