The law firm of Kessler Topaz Meltzer & Check, LLP announces that a securities fraud class action lawsuit has been filed in the United States District Court for the Northern District of California against FibroGen, Inc. (NASDAQ: FGEN) (“FibroGen”) on behalf of those who purchased or acquired FibroGen securities and/or sold put options from November 8, 2019 through April 6, 2021, inclusive (the “Class Period”).

Investor Deadline Reminder: Investors who purchased or acquired FibroGen securities during the Class Period may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453 or Adrienne Bell, Esq. (484) 270-1435; toll free at (844) 887-9500; via e-mail at info@ktmc.com; or click https://www.ktmc.com/fibrogen-class-action-lawsuit?utm_source=PR&utm_medium=Link&utm_campaign=fibrogen

FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat, 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. In 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”). FibroGen states that administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.

The Class Period commences on November 8, 2019 when FibroGen issued a press release announcing “Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results”. In the press release, and throughout the Class Period, FibroGen touted roxadustat as a safe treatment for anemia of CKD.

However, the truth was revealed on April 6, 2021 when, after the market closed, FibroGen issued a press release that revealed that FibroGen’s previously disclosed safety data included undisclosed post-hoc changes to the stratification factors and did not include analyses based on the pre-specified stratification factors. As a result of these changes, the complaint alleges that FibroGen was forced to concede that roxadustat, contrary to prior representations, did not reduce the risk of cardiovascular events or hospitalization as compared to a currently approved anemia injection used as a control based on pre-specified stratification factors. Following this news, FibroGen’s stock price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021.

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.

FibroGen investors may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

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