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 5, 2016
Kadmon Holdings, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
| 001-37841 |
| 27-3576929 |
(State or other jurisdiction of incorporation) |
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450 East 29th Street New York, NY |
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(Address of principal executive offices) |
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Registrant’s telephone number, including area code (212) 308-6000
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 (see General Instruction A.2. below):
☐ | 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)) |
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☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
ITEM 8.01 | Other Events. |
On December 5, 2016, Kadmon Holdings, Inc. (the “Company”) issued a press release announcing that it has submitted an Abbreviated New Drug Application for KD034, to the U.S. Food and Drug Administration (FDA). This is the first 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 | Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. | Description |
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99.1 | Press Release, dated December 5, 2016, issued by Kadmon Holdings, Inc. |
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: December 5, 2016 |
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| /s/ Konstantin Poukalov |
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| Konstantin Poukalov |
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| Executive Vice President, Chief Financial Officer |