koto_feja/E+ via Getty Images Updated to add the latest share price move. Falling 13%, Coherus BioSciences (NASDAQ:CHRS) is on track to record its biggest intraday loss since March 2020 as the FDA is expected to announce its decision on the marketing application for toripalimab as a treatment for nasopharyngeal carcinoma (NPC) today. About 2.9M Coherus (CHRS) shares have changed hands so far, compared to the 65-day average of ~1.0M.
Coherus (CHRS) develops the anti-PD-1 antibody in partnership with the Chinese biotech Shanghai Junshi Biosciences (OTCPK:SHJBF). In July, the companies said that the FDA accepted the biologics license application (BLA) for toripalimab in combination with chemotherapy as a first-line option for advanced recurrent or metastatic NPC. The BLA also includes a request to greenlight toripalimab monotherapy as a second-line or later treatment of recurrent or metastatic NPC following platinum-containing chemotherapy.
Last month, Coherus (CHRS) said that COVID-related restrictions impacted the FDA's ability to complete reviews in China. The partners 'are currently engaged in discussions with the FDA regarding opportunities to complete the inspections,' the company added. Seeking Alpha contributor Avisol Capital Partners argued in August, despite a Hold rating on Coherus (CHRS), that the PDUFA for toripalimab is a 'major catalytic event.'