CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) today announced financial results for the fourth quarter and year ended December 31, 2016.
Recent developments include:
The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) intends to release final guidance on bacterial contamination of platelets this year, according to its recently published Guidance Document Agenda for 2017.
Cerus estimates that at least 7 U.S. blood center customers, including the American Red Cross, have submitted biologics license applications to the FDA to request allowance for the interstate transport of INTERCEPT-treated platelet components.
Enrollment in SPARC, Cerus’ European chronic anemia trial, reached its target of at least 70 evaluable patients. Database lock is expected by the end of 2017 with data readout expected in early 2018.
Cerus’ planned INTERCEPT red blood cell CE mark submission has been extended pending completion of commercial lot release testing; optimization and validation of the release assay method are in progress.
Additional options totaling $10.8 million were exercised under Cerus’ contract with the Biomedical Advanced Research and Development Authority (BARDA) for INTERCEPT red blood cell development.
