Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against FibroGen, Inc. (NASDAQ: FGEN) on behalf of long-term stockholders following a class action complaint that was filed against FibroGen on April 12, 2021 with a Class Period from December 20, 2018 to July 15, 2021. Our investigation concerns whether the board of directors of FibroGen have breached their fiduciary duties to the company.
The complaint alleges that, 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. The complaint further alleges that 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, the complaint alleges, 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, on heavy volume. The complaint 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 are a long-term stockholder of FibroGen, 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 or Marion Passmore by email at investigations@bespc.com, by telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
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Contacts
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
