Item 8.01 Other Events.

On December 18, 2020, FibroGen, Inc. ("FibroGen") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has extended the review period of the New Drug Application ("NDA") for roxadustat for the treatment of anemia of chronic kidney disease by three months and the new Prescription Drug User Fee Act action date set by the FDA is March 20, 2021. The FDA is close to finalizing its review of the NDA and FibroGen is submitting additional analyses of existing roxadustat clinical data, which is considered a major amendment, thus granting the FDA three months for review.

A copy of such press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.






(d)  Exhibits

Exhibit No.    Description

99.1             Press Release titled "FibroGen Provides Regulatory Update on
               Roxadustat" dated December 18, 2020

104            Cover Page Interactive Data File (embedded within the Inline XBRL
               document)

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses