On November 8, 2019, FibroGen announced positive Phase 3 pooled roxadustat safety and efficacy results, noting the “the potential of roxadustat to improve treatment for anemia in CKD patients.” In December 2019, FibroGen filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for the approval of roxadustat for the treatment of anemia due to chronic kidney disease (“CKD”). On February 11, 2020, FibroGen announced that the FDA had completed its filing review of its NDA for roxadustat. In a regulatory update issued on December 18, 2020, FibroGen noted that the FDA extended its review period for roxadustat by three months and that it is submitting additional analyses of clinical data. Then, on April 6, 2021, FibroGen announced that in preparing for the upcoming FDA Advisory Committee meeting, the Company “became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors.” FibroGen acknowledged that it could no longer conclude that roxadustat reduces the risk of cardiovascular events or hospitalization when compared to a currently approved anemia injection used as a control. On this news, FibroGen’s share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021, and continued to fall on April 11, 2021, closing at $18.81 per share. The complaint alleges that throughout the Class Period, the defendants failed to disclose to investors that: (1) FibroGen’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia and certain safety analyses submitted in connection with CKD included post-hoc changes to the stratification factors; (2) FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (3) based on these analyses FibroGen could not 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; (4) as a result, FibroGen faced significant uncertainty that its NDA for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and (5) as a result of the foregoing, the defendants’ statements about FibroGen’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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