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)
Copyright (c) 2023 Dow Jones & Company, Inc.-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Going Into Earnings, Is Eli Lilly Stock a Buy, a Sell, or Fairly Valued?
-
What’s the Difference Between the CPI and PCE Indexes?
-
5 Stocks to Buy That We Still Like After They’ve Run Up
-
Markets Brief: Stocks Are Starting to Look Cheap Again
-
AbbVie Earnings: Next-Generation Immunology Drugs Help Offset Humira Biosimilar Pressure
-
Exxon Earnings: Ignore Earnings Shortfall as Long-Term Growth and Improvement on Track
-
American Airlines Earnings: We See Costs Overshadowing Market Share This Year
-
Snap Earnings: Advertising Growth and Snapchat+ Drive Monetization
-
STMicro Earnings: We Still See an Attractive Margin of Safety Despite a Poor First-Half Forecast
-
Alphabet Shares Surge on Strong Earnings, Dividend Surprise
-
Microsoft Earnings: Firm Beats Forecasts on Strong AI and Cloud Demand
-
PG&E Earnings: Near-Term Regulatory Certainty Supports Industry-Leading Earnings Growth