Current Report Filing (8-k)
October 18 2017 - 8:32AM
Edgar (US Regulatory)
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)
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Delaware
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001-36740
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77-0357827
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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FibroGen, Inc.
409 Illinois Street
San
Francisco, CA 94158
(Address of principal executive offices, including zip code)
(415)
978-1200
(Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to
Rule 14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to
Rule 13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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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. ☐
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 Companys submission of its New Drug Application (NDA) for registration of roxadustat
(FG-4592
or
), a novel oral investigational treatment for anemia in dialysis-dependent chronic kidney disease (CKD) and
non-dialysis-dependent
CKD patients. Under the terms of
FibroGens 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
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Financial Statements and Exhibits.
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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.
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F
IBROGEN
, I
NC
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Dated: October 18, 2017
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By:
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/s/ Michael Lowenstein
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Michael Lowenstein
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Chief Legal Counsel
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