Coherus BioSciences Shares Slip 9.6% on Lack of FDA Response to Toripalimab Application

By Denny Jacob

Coherus BioSciences Inc. shares slipped 9.6% to $5.83 on Tuesday after it said on Sunday that it hasn't received an action letter from the U.S. Food and Drug Administration regarding an application for one of its potential drugs, toripalimab.

The Redwood City, Calif., commercial-stage biopharmaceutical company said the FDA was unable to conduct an inspection of a plant belonging to Shanghai Junshi Biosciences Co. Ltd., a Chinese biopharmaceutical company collaborating on the drug's development.

The agency said an inspection of Shanghai Junshi's plant is required before the application can be approved, due to restrictions related to the Covid-19 pandemic.

The companies had submitted a biologics license application for toripalimab, in combination with chemotherapy, to be approved as treatment for recurrent or metastatic nasopharyngeal carcinoma, a head and neck tumor.

The companies said they are engaged in ongoing discussions with the FDA about the plant's pre-approval inspection plans.

Shares are down roughly 63% year-to-date.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

12-27-22 1155ET