Coherus BioSciences, Inc. CHRS shares are trading higher in Tuesday's after-hours session following the company's announcement of the U.S. Food and Drug Administration's (FDA) approval of UDENYCA ONBODY for pegfilgrastim-cbqv.
What To Know: The company announced the FDA approval after the close of the market on Tuesday. UDENYCA ONBODY is the company's on-body injector presentation of UDENYCA (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia.
It boasts features that are aimed to better aid patients, including an indicator and status light.
The approval was accompanied by a comprehensive analytical and clinical data package as well.
Paul Reider, Coherus' CCO, expressed optimism for UDENYCA ONBODY's future, saying, "Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs. We expect that UDENYCA ONBODY's five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors."
It is anticipated that UDENYCA ONBODY will be available commercially in the first quarter of 2024.
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CHRS Price Action: Shares of CHRS were up 25.70% at $2.74 in the after-hours session at the time of publication, according to Benzinga Pro.
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