Law Offices of Howard G. Smith reminds investors of the upcoming June 11, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired FibroGen Inc. securities between October 18, 2017 and April 6, 2021, inclusive (the “Class Period”).
Investors suffering losses on their FibroGen investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to email@example.com.
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 (“HIF-PH”) activity that acts by stimulating the body’s natural pathway for red cell production. In December 2019, the Company 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, on unusually heavy trading volume.
The complaint filed in this class action 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 certain safety analyses submitted in connection with FibroGen’s NDA for roxudustat included post-hoc changes to stratification factors; (2) that, based on analyses using the pre-specified stratification factors, the Company could not conclude that roxadustat reduces the risk of major adverse cardiovascular events compared to epoetin-alfa; (3) 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 (4) as a result, Defendants’ statements about its business, operations, and prospects were materially false and misleading and/or lacked reasonable basis at all relevant times.
If you purchased or otherwise acquired 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 if you meet certain legal requirements. To be a member of the class action 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 action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
Law Offices of Howard G. Smith
Howard G. Smith, Esquire