LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired FibroGen Inc. (“FibroGen” or the “Company”) (NASDAQ: FGEN) securities and/or sold put options between November 8, 2019 and April 6, 2021 inclusive (the “Class Period”). FibroGen investors have until June 11, 2021 file a lead plaintiff motion.
If you are a shareholder who suffered a loss, click here to participate.
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”).
On April 6, 2021, after the market closed, FibroGen 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, the Company stated that the safety analyses “included post-hoc changes to the stratification factors.” FibroGen 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.”
On this news, the Company’s share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021, thereby injuring investors. The share price continued to fall during the next trading session by $0.93, or 4.7%, to close at $18.81 per share on April 8, 2021, thereby injuring investors further.
The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia certain safety analyses submitted in connection with CKD included post-hoc changes to the stratification factors; (2) that FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (3) 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; (4) 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 (5) that, as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
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If you purchased FibroGen securities during the Class Period, you may move the Court no later than June 11, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased FibroGen securities, have information or 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 Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to firstname.lastname@example.org, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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