Cerus provides updates on INTERCEPT red blood cell programs in U.S., Europe

Cerus Corporation announced updates on the INTERCEPT red blood cell programs in the U.S. and in Europe: New $248 million BARDA contract in U.S. supports program beyond U.S. Phase 3 studies through anticipated PMA licensure and into commercialization; CE Mark review in Europe has been concluded without approval, though the company is assessing strategy for anticipated future filing. “We are pleased with the progress we have made with our U.S. RBC program, which will now receive additional support from BARDA through a new contract valued at up to $248 million, intended to fund activities including continued improvement in the design of the product candidate and a future scale-up of commercial manufacturing activities,” commented Obi Greenman, Cerus’ president and chief executive officer. “In Europe, our CE Mark review under the Medical Device Regulation (MDR) has concluded without an approval. We believe that we can address the issues which prevented our approval in the context of an anticipated new regulatory submission.”