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, 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 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”). FibroGen states that administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.
The Class Period commences on December 20, 2018, when FibroGen announced positive topline results from its Phase 3 trials of Roxadustat. Specifically, FibroGen claimed that Roxadustat had “achieved superiority in efficacy not only against placebo but also over active comparator in our studies,” Epogen. Throughout the Class Period, FibroGen touted the success of Roxadustat’s Phase 3 trials, and the drug’s preferable safety analysis figures as compared to the current standard of care drug.
The truth began to emerge on March 1, 2021 when, after the market closed, FibroGen announced that the FDA was scheduling an advisory committee meeting to review Roxadustat’s NDA, well over a year after its initial submission. An advisory committee meeting this late in the review process indicates that there is a problem with the application, and could, at best, delay the FDA’s approval decision and at worst signal that the FDA may not approve the drug. Following this news, FibroGen’s stock price fell by $12.46 per share, or 25%.
Then, 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 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. 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 FibroGen’s statements and omissions during the Class Period were materially false and misleading because FibroGen had made post-hoc changes to Roxadustat’s Phase 3 trial results that made the drug appear safer than it was. When the data manipulation was corrected, FibroGen could “no longer make the conclusion that [Roxadustat] ha[s] statistically superior result[s]” when compared to Epogen.
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 email@example.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.