false 0000921299 0000921299 2020-02-11 2020-02-11




Washington, D.C. 20549





Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 11, 2020


FibroGen, Inc.

(Exact name of registrant as specified in its charter)








(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)

FibroGen, Inc.

409 Illinois Street

San Francisco, CA 94158

(Address of principal executive offices, including zip code)

(415) 978-1200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, $0.01 par value


The Nasdaq Global Select Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).


Emerging growth company      


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.      


Item 8.01

Other Events.

On February 11, 2020, FibroGen, Inc. (“FibroGen”) announced acceptance by the U.S. Food and Drug Administration (the “FDA”) of FibroGen’s New Drug Application (the “NDA”) for roxadustat for the treatment of anemia of chronic kidney disease, in both non-dialysis-dependent and dialysis-dependent patients. The FDA notified us that it has completed its filing review, and the NDA will be considered filed on February 18, 2020. The FDA has set a Prescription Drug User Fee Act goal date of December 20, 2020. The filing of the NDA triggers a $50 million milestone payment to FibroGen from AstraZeneca, its collaboration partner for the U.S.


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.







Exhibit No.







Press Release titled “FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease” dated February 11, 2020






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



Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.




Dated: February 11, 2020





/s/ Michael Lowenstein




Michael Lowenstein




Chief Legal Officer


Historical Stock Chart
From Jul 2020 to Aug 2020 Click Here for more FibroGen Charts.
Historical Stock Chart
From Aug 2019 to Aug 2020 Click Here for more FibroGen Charts.