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NEWS
Cerus Corporation Provides Updates on INTERCEPT Red Blood Cell Programs in the U.S. and Europe
Cerus (Nasdaq:CERS) has provided updates on its INTERCEPT red blood cell (RBC) programs in the U.S. and Europe. In the U.S., Cerus has secured a new $248 million contract with BARDA to support the program through FDA approval and commercialization. The company recently announced positive topline results for the ReCePI study, a pivotal U.S. Phase 3 clinical trial.
In Europe, the CE Mark review under the Medical Device Regulation (MDR) has concluded without approval. Cerus is assessing strategies for a potential new regulatory submission. The company remains confident in the need for pathogen inactivated RBCs and plans to leverage additional data, including results from the U.S. Phase 3 ReCePI trial, for a potential new CE Mark submission.
In Europe, the CE Mark review under the Medical Device Regulation (MDR) has concluded without approval. Cerus is assessing strategies for a potential new regulatory submission. The company remains confident in the need for pathogen inactivated RBCs and plans to leverage additional data, including results from the U.S. Phase 3 ReCePI trial, for a potential new CE Mark submission.
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