NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of investors that purchased FibroGen, Inc. (NASDAQ: FGEN) securities and/or sold put options from November 8, 2019 and April 6, 2021, inclusive (the “Class Period”). Investors have until June 11, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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On August 18, 2019, the Company issued a press release announcing, “Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results” and that shortly thereafter on December 23, 2019, FibroGen announced that it had submitted a New Drug Application to the Food and Drug Administration for roxadustat.
On April 6, 2021, the Company revealed that its 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, 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.
On this news, the Company’s share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021.
The complaint, filed on April 12, 2021, alleges that defendants failed to disclose to investors: (i) that the Company’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of CKD included post-hoc changes to the stratification factors; (ii) that FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (iii) that, based on these analyses, the Company 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; (iv) that, as a result, the Company faced significant uncertainty that its NDA for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and (v) that, as a result of the foregoing, defendants’ statements about the Company's business, operations and prospects were materially misleading and/or lacked a reasonable basis.
If you purchased FibroGen securities during the Class Period and suffered a loss, are a long term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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