Coherus BioSciences (NASDAQ:CHRS) announced that the United States Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for Toripalimab in combination with Gemcitabine and Cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC)
The regulatory agency has set Prescription Drug User Fee Act (PDUFA) action date for December 23, 2022.
Denny Lanfear, CEO, commented : “For Coherus, the toripalimab resubmission is one of several key development and commercialization milestones we are sharply focusing on over the next twelve months, and we are pleased with the Company's execution and progress on all of them.”
The FDA earlier communicated that the review timeline for the BLA resubmission would be six months, as onsite inspections in China would be required.
If approved, the company plans to launch Toripalimab in the United States during the first quarter of 2023.
Coherus shares closed Tuesday’s trading up 9 percent at $8.54.
