Coherus BioSciences recently received news that the U.S. Food and Drug Administration (FDA) has rejected its submission for regulatory approval of their new on-body injector form of Udenyca. Udenyca is a treatment specifically designed to minimize the risk of infection in cancer patients undergoing chemotherapy.
The rejection was not related to any issues surrounding the clinical efficacy, safety, or device design of Udenyca Onbody. Instead, it was due to an ongoing review of inspection findings at a third-party filler. Coherus BioSciences explicitly stated that there were no concerns regarding the product’s effectiveness or safety.
Despite this setback, Coherus remains committed to collaborating closely with both the FDA and the third-party filler in order to expedite the availability of the new injector for patients. Efforts are being made to address any issues and ensure that Udenyca Onbody can be brought to market as swiftly as possible.
Additionally, the FDA has completed inspections at three clinical study sites in China, where subjects were enrolled in two crucial clinical trials for toripalimab in the treatment of nasopharyngeal carcinoma. Coherus reported that only one minor observation was made during these inspections, and it is a matter that can be easily resolved. Therefore, Coherus anticipates potential approval for toripalimab by the end of this year.
As a result of this news, Coherus shares experienced a 2% increase in premarket trading on Monday. It is worth noting that Coherus shares have declined by 43.7% so far this year, while the S&P 500 has recorded a gain of 12.5%.