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If you purchased a significant amount of shares of FibroGen, Inc. (NASDAQ: FGEN) between November 8, 2019 and April 6, 2021, and / or if you purchased any NASDAQ: FGEN shares prior to November 2019 and continue to hold any of those shares, you have certain options and for certain investors are short and strict deadlines running. Deadline: June 11, 2021. NASDAQ: FGEN investors should contact the Shareholders Foundation, Inc.
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To have your information reviewed for options and to receive notifications about this case, please send an email to mail@shareholdersfoundation.com, or call us at (858) 779-1554.
Lawsuit Overview
April 12, 2021 - An investor in shares of FibroGen, Inc. (NASDAQ: FGEN) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by FibroGen, Inc. in connection with certain allegedly false and misleading statements made between November 8, 2019 and April 6, 2021.
San Francisco, CA based FibroGen, Inc., a biopharmaceutical company, discovers, develops, and commercializes therapeutics to treat serious unmet medical needs.
On August 18, 2019, FibroGen, Inc. announced "Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results" and that shortly thereafter on December 23, 2019, FibroGen, Inc. announced that it had submitted a New Drug Application to the Food and Drug Administration for roxadustat.
On April 6, 2021, after the market closed, FibroGen, Inc. issued a statement “provid[ing] clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease (‘CKD’).”
Specifically, FibroGen, Inc. stated that the safety analyses “included post-hoc changes to the stratification factors.” FibroGen, Inc. further revealed that, based on analyses using the pre-specified stratification factors, the Company “cannot 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.” Shares of FibroGen, Inc. (NASDAQ: FGEN) declined to $18.12 per share on April 9, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of FibroGen, Inc. (NASDAQ: FGEN) common shares between November 8, 2019 and April 6, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between November 8, 2019 and April 6, 2021, the Defendants failed to disclose to investors 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, that FibroGen's analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals, 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, 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 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.