Form 8-K

 

 

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): October 18, 2017

 

 

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))

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 October 18, 2017, FibroGen, Inc. (Company) and its subsidiary, FibroGen China Medical Technology Development Co., Ltd., announced that the China Food and Drug Administration has accepted the Company’s submission of its New Drug Application (NDA) for registration of roxadustat (FG-4592 or LOGO ), a novel oral investigational treatment for anemia in dialysis-dependent chronic kidney disease (CKD) and non-dialysis-dependent CKD patients. Under the terms of FibroGen’s agreement with AstraZeneca AB, a collaboration partner of the Company, the NDA submission triggers a $15 million milestone payment, payable to the Company by AstraZeneca.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  

Description

99.1    Press Release titled “FibroGen Announces Acceptance by China FDA of Roxadustat New Drug Application (NDA) for Treatment of Anemia Associated with Dialysis and Non-Dialysis Chronic Kidney Disease (CKD)” dated October 18, 2017


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: October 18, 2017    
    By:  

/s/ Michael Lowenstein

      Michael Lowenstein
      Chief Legal Counsel