Cases / Investigations

FibroGen, Inc.


Company Name:         FibroGen, Inc.
Securities:                   FGEN (NASDAQ)    
Class Period:               November 9, 2019 to April 6, 2021   
Lead Plaintiff  
Motion Deadline:         June 11, 2021
Court:                          United States District Court for the Northern District of California

FibroGen is a biopharmaceutical company. One of its lead drugs is roxadustat, which promotes red blood cell production. Roxadustat is currently approved for sale in China, Japan and Chile for treatment of anemia for patients with chronic kidney disease.

FibroGen submitted a New Drug Application (NDA) to the FDA for roxadustat in December 2019. On March 1, 2021, the FDA informed FibroGen that the Cardiovascular and Renal Drugs Advisory Committee would hold an advisory committee meeting to review the NDA for roxadustat. That news was unexpected and caused FibroGen’s stock price to fall almost 25% to $38.07 per share.

After the market closed on April 6, 2021, FibroGen announced that while it was preparing for the Advisory Committee meeting, it became “aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors” and that it  ”promptly decided to clarify this issue with the FDA.”  Adam Feuerstein, the biotech reporter at STAT+, said “Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental anemia pill for at least two years — a shocking revelation that raises even more questions about the drug’s approvability.”

On this news, FibroGen’s stock price fell $14.90 per share, or 43%, and closed at $19.74 per share on April 7, 2021. 

The FibroGen securities class action litigation alleges, among other things, that the defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements or failing to disclose material facts concerning the heart safety data and anlysis for roxadustat.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased FibroGen securities during the Class Period to ask the court to be appointed as lead plaintiff in the FibroGen securities class action litigation.  A lead plaintiff acts on behalf of all other class members in directing the class action lawsuit, and can select a law firm of its choice to litigate the class action lawsuit.  A court will generally appoint as lead plaintiff the movant with the greatest financial interest in the relief sought by the proposed class of investors and is also typical and adequate of the proposed class.  An investor’s ability to share in any potential future recovery obtained in the litigation is not dependent upon serving as lead plaintiff. 

If you wish to serve as lead plaintiff in the FibroGen securities class action litigation or have questions concerning your rights regarding the FibroGen securities class action litigation, please contact Joshua Ruthizer at (212) 451-9668, (877) 370-7703, or jruthizer@wolfpopper.com. 

The deadline for FibroGen investors to file a motion for appointment as lead plaintiff is June 11, 2021.

For further information about this case, contact:

Robert C. Finkel
rfinkel@wolfpopper.com

Joshua W. Ruthizer
jruthizer@wolfpopper.com


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