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FIBROGEN INC Regulatory Filings 2019

Dec 23, 2019

34576_rns_2019-12-23_ef3a4337-ad90-41df-833d-abc3ef3b9884.zip

Regulatory Filings

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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): December 23, 2019

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 8.01 Other Events

On December 23, 2019, FibroGen, Inc. issued a press release announcing the submission of a New Drug Application to the U.S. Food and Drug Administration for roxadustat for the treatment of anemia of chronic kidney disease in both non-dialysis-dependent and dialysis-dependent patients.

A copy of such press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

Exhibits

Exhibit No. Description
99.1 Press Release titled “FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients with Anemia of Chronic Kidney Disease” dated December 23, 2019
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.

Dated: December 23, 2019
By: /s/ Michael Lowenstein
Michael Lowenstein
Chief Legal Officer