Current Report Filing (8-k)
April 04 2017 - 9:11AM
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)
:
April 4, 2017 (
March 31, 2017
)
Kadmon Holdings
, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-
37841
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27
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3576929
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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450 East 29
th
Street
New York, NY
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10016
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code (
212
) 3
08
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6000
N/A
(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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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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On
March 31
, 2017
, Kadmon Holdings, Inc. (the “Company”)
submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA)
for KD034,
the Company’s trientine hydrochloride formulation
. This is the
second
application submitted to the FDA by any company for a generic trientine hydrochloride product for the treatment of Wilson’s disease in patients who are intolerant of penicillamine. Wilson’s disease is a genetic liver disease characterized by an inability to excrete copper, causing severe hepatic, neurologic, psychiatric and ophthalmic abnormalities
. The full text of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
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ITEM 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit No.
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Description
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99.1
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Press Release, dated
April 4
, 2017
, issued by Kadmon Holdings, Inc.
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SIGNATURE
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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Kadmon Holdings, Inc.
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Date:
April 4
, 2017
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/s/ Konstantin Poukalov
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Konstantin Poukalov
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Executive Vice President, Chief Financial Officer
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