Shares of Coherus BioSciences Inc. (CHRS) - Get Report fell 32.2% to $14 in premarket trading on Monday, June 12, on the heels of the Redwood City, Calif.-based firm's announcement that the U.S. Food and Drug Administration has issued a "complete response letter" (CRL) asking for more information about its license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway.
"The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information," Coherus said.
Coherus said it will work with the agency to address the information requests.
The Austin, Texas-based firm on June 9 said it was discontinuing its Phase 3 XCITE study for its candidate antibody therapy for the treatment of colorectal cancer based on a second interim analysis by an independent data monitoring committee.
While the committee had no safety concerns from the analysis, it "recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation," XBiotech said.
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