FibroGen investors may receive additional information about the case by clicking the link "Submit Your Information" above.
FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat (“Roxa”), an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase activity that acts by stimulating the body’s natural pathway for red cell production.
The Class Period commences on October 18, 2017 when FibroGen announced that the China Food and Drug Administration had accepted its new drug application (“NDA”) for Roxa based on two Phase 3 studies in China, “one study in CKD [chronic kidney disease] comparing roxadustat against a branded epoetin alfa[] and one study in CKD non-dialysis comparing roxadustat against placebo.” Both studies had “met their primary efficacy endpoints with no new or unexpected safety signals identified.”
On April 6, 2021, after the market closed, FibroGen issued a press release that revealed that FibroGen’s 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 that FibroGen was forced to concede that Roxa, 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. Following this news, FibroGen’s stock price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements or failed to disclose that: (1) based on the safety data from FibroGen’s two Phase 3 trials in China, any safety data obtained from the global Phase 3 trials would require post-hoc changes to the stratification factors to meet the U.S. Food and Drug Administration’s (“FDA”) requirements; (2) FibroGen’s disclosures of U.S. primary cardiovascular safety analyses from the Roxa global Phase 3 program for the treatment of anemia submitted in connection with CKD included post-hoc changes to the stratification factors; (3) FibroGen’s analyses with the pre-specified stratification factors resulted in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (4) based on these analyses, FibroGen could not conclude that Roxa reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (5) as a result, FibroGen faced significant uncertainty that its NDA for Roxa as a treatment for anemia of CKD would be approved by the FDA; and (6) as a result of the foregoing, the defendants’ statements about FirboGen’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
If you are a member of the class described above, you may no later than June 11, 2021 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453 or Adrienne Bell, Esq. (484) 270-1435; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.