|Abeona Therapeutics Inc., of New York||EB-101||Autologous, gene-corrected cell therapy||Recessive dystrophic epidermolysis bullosa||FDA removed clinical hold after company submitted additional data points on transport stability of the therapy; study expected to begin in the first quarter of 2020|
|Aptevo Therapeutics Inc., of Seattle||APVO-436||Bispecific antibody targeting CD123 and CD3||Acute myelogenous leukemia||FDA granted orphan drug designation|
|Galderma SA, of Lausanne, Switzerland||Nemolizumab||Monoclonal antibody targeting IL-31 receptor alpha||Prurigo nodularis||FDA granted breakthrough therapy designation|
|Gensight Biologics SA, of Paris||Lumevoq (GS-010)||Gene therapy||Leber hereditary optic neuropathy||French Competent Authority, the National Drug Safety Agency, granted a named patient temporary authorization for use to the National Eye Hospital of the Quinze-Vingts|
|Iontas Ltd., of Cambridge, U.K., and International Biotechnology Center Generium, of Moscow||Undisclosed||CD3/CD19 bispecific antibody||Acute lymphoblastic leukemia||Received approval from the Russian Health Authorities to initiate clinical trials|
|Janssen Pharmaceutical Co., of Raritan, N.J., a unit of Johnson & Johnson||JNJ-68284528 (JNJ-4528)||CAR T targeting B-cell maturation antigen||Previously treated patients with multiple myeloma||FDA granted breakthrough therapy designation|
|Sesen Bio Inc., of Cambridge, Mass.||Vicinium||Fusion protein that targets epithelial cell adhesion molecule and delivers Pseudomonas exotoxin A||BCG-unresponsive non-muscle invasive bladder cancer||Started rolling submission of BLA to the FDA|
For more information about individual companies and/or products, see Cortellis.