Shares of Coherus BioSciences (CHRS 5.70%) are up 19.7% as of 3:20 p.m. ET Thursday after the U.S. Food and Drug Administration (FDA) approved Udenyca OnBody, the company's on-body injection system that can be taken to prevent infection in chemotherapy patients.
A long-awaited FDA approval
Recall shares of Coherus fell under pressure back in September after the FDA issued a complete response letter (CRL) for its Udenyca OnBody biologics license application. Coherus was quick to point out the agency did not raise concerns about Undenyca's labeling, efficacy, or safety, but was rather concerned over potential issues at a third-party manufacturing site for the system.
Sure enough, Coherus resubmitted that application in October following the completion and satisfactory resolution of the FDA's review. And during the company's subsequent earnings conference call last month, management told investors it expected the potential approval to arrive either late this year or by early 2024. From an investor's standpoint, it's obviously encouraging that Coherus received its formal approval on the earlier end of that range.
What's next for Coherus stock?
Coherus CEO Denny Lanfear noted Coherus OnBody resulted from years of significant investment in R&D for the novel device.
"Cancer patients and their physicians will now be able to choose the UDENYCA administration presentation that best fits their individual needs: A prefilled syringe, our autoinjector, or this on-body injector," Lanfear added.
Coherus is now planning commercial availability of Udenyca OnBody for the first quarter of 2024. Considering delays in this commercial launch were partly to blame for Coherus' recently reduced 2023 guidance, it's no surprise to see shares rebounding today.
