Coherus BioSciences (NASDAQ:CHRS), along with Shanghai Junshi Biosciences Co., announced that they haven’t received an action letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as the treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).
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Recurrent or metastatic NPC is a head and neck tumor that has no FDA-approved treatments. CHRS stock declined nearly 12% on Tuesday in reaction to the company’s update. Shares have plunged over 64% year-to-date.
The FDA had earlier communicated that an on-site inspection of Junshi Biosciences’ manufacturing facility for toripalimab is required before it can approve the BLA. However, the regulatory body could not conduct the inspection within the current review cycle due to COVID-led travel restrictions in China. Coherus stated that the BLA for toripalimab remains under review and the two companies are discussing the pre-approval inspection plans with the FDA.
The FDA granted priority review for the toripalimab BLA for use in combination with gemcitabine and cisplatin as the first-line treatment for patients with advanced recurrent or metastatic NPC. The priority review also included toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
Is Coherus a Buy?
Coherus earns the Street’s Strong Buy consensus rating based on four Buys and one Hold. The average CHRS stock price prediction of $18.20 implies nearly 220% upside potential.
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