It is alleged in this complaint that FibroGen issued misleading and/or false statements and/or failed to disclose information pertinent to investors.On April 6, 2021, FibroGen issued a statement providing “clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease (‘CKD’).” FibroGen stated that its safety analysis “included post-hoc changes to the stratification factors.” FibroGen also disclosed, based on analyses using the pre-specified stratification factors, that FibroGen “cannot conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa.” Shares of FibroGen dropped sharply, based on this news.
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