Toll free (844) 887-9500 FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat ("Roxa"), an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase activity that acts by stimulating the body's natural pathway for red cell production. The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements or failed to disclose that: (1) based on the safety data from FibroGen's two Phase 3 trials in China, any safety data obtained from the global Phase 3 trials would require post-hoc changes to the stratification factors to meet the U.S. Food and Drug Administration's ("FDA") requirements; (2) FibroGen's disclosures of U.S. primary cardiovascular safety analyses from the Roxa global Phase 3 program for the treatment of anemia submitted in connection with chronic kidney disease ("CKD") included post-hoc changes to the stratification factors; (3) FibroGen's analyses with the pre-specified stratification factors resulted in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (4) based on these analyses, FibroGen could not conclude that Roxa reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (5) as a result, FibroGen faced significant uncertainty that its NDA for Roxa as a treatment for anemia of CKD would be approved by the FDA; and (6) as a result of the foregoing, the defendants' statements about FirboGen's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.