Coherus' Udenyca Body Injector At par With Pre-filled syringe

Coherus BioSciences Inc CHRS announced results from a bioequivalence study of Udenyca (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed Udenyca pre-filled syringe (PFS).
The study met all PK bioequivalence primary endpoints and the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count).
No new safety signals were observed.
The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of Udenyca OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks.
Coherus plans a 2022 submission to the FDA of a prior approval supplement to seek marketing authorization for the UDENYCA® OBI and anticipates a standard 10-month review period.
Coherus expects the commercial launch of the Udenyca OBI directly post-approval.
Udenyca is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies.
Price Action: CHRS stock is up 4.11% at $16.46 during the market session on the last check Tuesday.