FDA Rejects Junshi - Coherus' Toripalimab For Rare Head & Neck Cancer - Coherus BioSciences (NASDAQ:CHRS)

The FDA has issued a complete response letter (CRL) to Junshi Biosciences Co Ltd and Coherus BioSciences Inc's CHRS toripalimab application for advanced recurrent or metastatic nasopharyngeal carcinoma (NPC).
NPC is a rare tumor of the head and neck which originates in the nasopharynx, located behind the nose and above the back of the throat.
The application seeks approval for toripalimab combined with gemcitabine and cisplatin in the first-line treatment of NPC and toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
Related: Junshi Biosciences - Coherus Toripalimab Chemo Combo Met Survival Endpoints In Lung Cancer Setting.
The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable.
Coherus and Junshi Biosciences plan to meet with the FDA directly and expect to resubmit the application by mid-summer 2022.
The Agency also communicated in the CRL that the review timeline for the application resubmission would be six months, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.
Price Action: CHRS shares are down 2.65% at $8.80 during the premarket session on the last check Monday.