By Shares of Coherus BioSciences dropped on Monday following an announcement that the FDA has issued a complete response letter rejecting a biologics license application supplement for Udenyca Onbody’s injectors.
Share Price Decline
As of 3:31 pm E.T., Coherus BioSciences’ shares were down by 9% to $4.06. The stock has experienced a significant decline of 48% since the beginning of the year.
Reason for Rejection
Coherus BioSciences, a commercial-stage biopharmaceutical company, stated that the lack of approval stems from an ongoing review of inspection findings at a third-party filler. However, the company emphasized that the complete response letter did not indicate any concerns with the Udenyca Onbody’s clinical efficacy or safety.
Commitment to Working with FDA
Despite the setback, Coherus BioSciences remains determined to collaborate closely with the FDA and the third-party filler to expedite the availability of Udenyca Onbody for cancer patients who require pegfilgrastim treatment.
Importance of Pegfilgrastim Injections
Pegfilgrastim injections play a crucial role in reducing the risk of infections among cancer patients undergoing chemotherapy.
Complete Response Letter
The FDA issues a complete response letter when the review cycle for an application is finalized, but it is determined that the application is not yet ready for approval.
In conclusion, Coherus BioSciences is actively addressing the FDA’s concerns to ensure the swift availability of Udenyca Onbody’s injectors for cancer patients in need of pegfilgrastim treatment.
Coherus BioSciences Faces Setback as FDA Rejects License Application Supplement
Shares of Coherus BioSciences experienced a decline on Monday following the news that the U.S. Food and Drug Administration (FDA) issued a complete response letter rejecting a biologics license application supplement for Udenyca Onbody’s injectors.
At 3:31 pm E.T., Coherus BioSciences’ shares were down by 9%, resulting in a share price of $4.06. The stock has seen a significant decrease of 48% since the beginning of the year.
Coherus BioSciences, a commercial-stage biopharmaceutical company, explained that the lack of approval was due to an ongoing review of inspection findings related to a third-party filler.
To clarify, the complete response letter did not highlight any concerns regarding the clinical efficacy or safety of Udenyca Onbody, according to the company.
Coherus BioSciences expressed its commitment to closely collaborate with the FDA and the third-party filler to expedite the availability of Udenyca Onbody to cancer patients who require pegfilgrastim treatment.
Pegfilgrastim injections are essential in minimizing the risk of infections among cancer patients undergoing chemotherapy treatment.
In this case, the FDA’s issuance of a complete response letter indicates that the review process for the application is completed, but further work is needed before approval can be granted.
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