false 0000921299 0000921299 2021-04-06 2021-04-06

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

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

Date of Report (Date of earliest event reported): April 6, 2021

 

FibroGen, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-36740

 

77-0357827

(State or other jurisdiction

of incorporation)

 

(Commission

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

FGEN

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 7.01

Regulation FD Disclosure

On April 6, 2021, FibroGen, Inc. (“FibroGen”) announced that the U.S. Food and Drug Administration (the “FDA”) informed FibroGen late on Tuesday, April 6, 2021, that the FDA has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee meeting on July 15, 2021 to review the New Drug Application for roxadustat for the treatment of anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients.

 

The information in this Item 7.01 is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in Item 7.01 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider his information before making an investment decision with respect to any security of the Company.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press Release titled “FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021” dated April 6, 2021

 

 

 

104

 

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

 


 

SIGNATURES

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.

 

 

FIBROGEN, INC.

Dated: April 6, 2021

 

 

By:

 

/s/ Michael Lowenstein

 

 

 

Michael Lowenstein

 

 

 

Chief Legal Officer

 

FibroGen (NASDAQ:FGEN)
Historical Stock Chart
From Feb 2024 to Mar 2024 Click Here for more FibroGen Charts.
FibroGen (NASDAQ:FGEN)
Historical Stock Chart
From Mar 2023 to Mar 2024 Click Here for more FibroGen Charts.