| COMPANY |
FibroGen, Inc. |
| COURT |
United States District Court for the Northern District of California |
| CASE NUMBER |
21-cv-02623 |
| JUDGE |
The Honorable Edward M. Chen |
| CLASS PERIOD |
November 8, 2019 - April 6, 2021 |
| SECURITY TYPE |
All Securities |
Case Background:
This is a federal securities class action brought on behalf of all persons who purchased or acquired FibroGen securities between November 18, 2019 through April 6, 2021, (“Class Period”) both dates inclusive. On April 12, 2021, the initial complaint was filed against FibroGen Inc. (“FibroGen” or the “Company”) and certain of Fibrogen’s directors and officers, asserting violations of Sections 10(b) and 20(a) of the Securities Exchange Act.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations and compliance policies. Specifically, the complaint alleges that Defendants failed to disclose to investors that: (1) 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) FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (3) 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) 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) 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.
Current Status of Case:
On May 28, 2024, the Court entered Order approving plan of allocation and granting final approval of settlement. This action has concluded.
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: Jon Naji, Esq. (484) 270-1453; 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.