Coherus BioSciences, Inc. (NASDAQ: CHRS) shares experienced a notable upswing of 37.16%, reaching $2.99 in the extended trading session on Tuesday. In the regular trading session, Coherus stock also displayed a commendable increase of 7.92%, concluding at $2.18. This surge in CHRS stock value ensued subsequent to the announcement of regulatory approval.
Coherus (CHRS) yesterday announced the approval of UDENYCA ONBODY by the Food and Drug Administration (FDA). UDENYCA is an on-body injector (OBI) used to reduce the risk of infection, namely febrile neutropenia. It is a biosimilar of pegfilgrastim effectively used after a chemotherapy.
The development of the OBI for UDENYCA represents the culmination of substantial investments in research and development, resulting in a pioneering and exclusive device affording patients an automated delivery alternative for their medication. This milestone empowers cancer patients and their healthcare providers to opt for the UDENYCA administration method that aligns with their specific requirements, whether it be a prefilled syringe, an autoinjector, or Coherus’ OBI.
Market analyses have indicated a pronounced demand for an innovative on-body pegfilgrastim delivery apparatus customized to the unique needs of patients. Coherus anticipates a positive reception for UDENYCA ONBODY, attributing its appeal to the device’s brief five-minute injection duration and innovative retractable needle mechanism, which is expected to resonate well with cancer patients, their caregivers, and medical professionals.
UDENYCA ONBODY’s patient-centric design includes features such as an indicator with a status light and audible signals to assist patients in confirming the administered dose. Moreover, it incorporates a robust and well-tolerated adhesive. Notably, following the administration of the dose, the needle automatically retracts, minimizing the risk of needlestick injuries.
The regulatory approval for UDENYCA ONBODY was underpinned by an exhaustive package of analytical and clinical data, encompassing pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data, as well as data on adhesive performance and tolerability. Coherus is strategically planning the commercial availability of UDENYCA ONBODY in the first quarter of 2024.
