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FibroGen, Inc. Class Action Lawsuit

Company Name
FibroGen, Inc.
Stock Symbol
FGEN
Class Period
November 8, 2019 to April 6, 2021
Motion Deadline
June 11, 2021
Court
Northern District of California
24 days left to seek lead plaintiff status

Case Summary

The FibroGen, Inc. class action lawsuit charges FibroGen and certain of its executives with violations of the Securities Exchange Act of 1934 and seeks to represent all persons and entities who purchased or otherwise acquired FibroGen securities and/or sold FibroGen put options from November 8, 2019 through and including April 6, 2021 (the “Class Period”).  The FibroGen class action lawsuit was commenced on April 12, 2021 in the Northern District of California and is captioned Xu v. FibroGen, Inc., No. 21-cv-02623.

FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.  FibroGen’s 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”).  Cardiovascular endpoints included: (1) Time to first Major Adverse Cardiovascular Event (MACE), a composite endpoint of all-cause mortality, myocardial infarction, and stroke; and (2) Time to first MACE+, a composite endpoint which includes MACE plus unstable angina and heart failure requiring hospitalization.

The FibroGen class action lawsuit alleges that, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) FibroGen’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia and certain safety analyses submitted in connection with CKD included post-hoc changes to the stratification factors; (ii) FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (iii) based on these analyses, FibroGen 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; (iv) consequently, FibroGen faced significant uncertainty that its NDA for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and (v) as a result of the foregoing, defendants’ statements about FibroGen’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis

On April 6, 2021, FibroGen disclosed that “[a]s members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors.”  FibroGen further revealed that “the analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals,” that “[f]or MACE+ in dialysis and for MACE and MACE+ in incident dialysis, the 95% confidence intervals include 1.0,” and that “[w]hile these hazard ratios remain below 1.0, based on these analyses we 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, FibroGen’s share price fell approximately 43%, damaging investors.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased FibroGen securities and/or sold FibroGen put options during the Class Period to seek appointment as lead plaintiff in the FibroGen class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the FibroGen class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the FibroGen class action lawsuit.  An investor’s ability to share in any potential future recovery of the 3D Systems action lawsuit is not dependent upon serving as lead plaintiff.  If you wish to serve as lead plaintiff of the FibroGen class action lawsuit or have questions concerning your rights regarding the FibroGen class action lawsuit, please provide your information here or contact counsel, Michael Albert of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at malbert@rgrdlaw.com.  Lead plaintiff motions for the FibroGen class action lawsuit must be filed with the court no later than June 11, 2021.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation.  With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history.  For eight consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements.  Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims.  Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide.  Robbins Geller attorneys are consistently recognized by courts, professional organizations and the media as leading lawyers in the industry.

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