Coherus BioSciences Shares Drop 9% on FDA's Application Rejection

By Sabela Ojea

Shares of Coherus BioSciences on Monday fell after the company said the FDA issued a complete response letter to reject a biologics license application supplement for Udenyca Onbody's injectors.

At 3:31 pm E.T., shares were down 9% to $4.06. The stock has plunged 48% since the year started.

The commercial-stage biopharmaceutical company said the lack of approval came as a result of an ongoing review of inspection findings at a third-party filler.

The complete response letter didn't identify any issues with the Udenyca Onbody clinical efficacy or safety, the company said.

"Coherus is committed to working closely with the FDA and the third-party filler to bring Udenyca Onbody to cancer patients requiring pegfilgrastim treatment as quickly as possible," it added.

Pegfilgrastim injections are used to reduce the chance of infections in cancer patients going through chemotherapy.

The FDA sends applicants a complete response letter to indicate the review cycle for an application is complete but the application is not ready for approval.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

September 25, 2023 16:02 ET (20:02 GMT)

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