Coherus, Junshi Biosciences Get FDA Complete Response Letter (1)

(Updates to add CHRS shares and context.)

Shanghai Junshi Biosciences and Coherus BioSciences received a complete response letter from the U.S. Food and Drug Administration for use of the PD-1 inhibitor toripalimab in head and neck cancers.

• CHRS shares fall 2.7% in U.S. premarket trading
• The Biologics License Application is for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy
• Letter requests a quality process change that Coherus and Junshi Biosciences ...