Coherus BioSciences Inc said on Wednesday that the U.S. Food and Drug Administration (FDA) flagged three observations at its partner Shanghai Junshi Biosciences Ltd's manufacturing site in China for its experimental cancer drug.
The company said it believed that the observations received are readily addressable and it plans to submit its response to the FDA in early June.
Coherus shares were last trading down 8% at $3.81.
The U.S. health regulator delayed its decision on the drug in December, as its team had been unable to travel to China to conduct the required site inspection.
The company is seeking approval for the drug, toripalimab, for patients with nasopharyngeal carcinoma, an aggressive type of head and neck cancer.
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