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EX-99.1 - EX-99.1 - Kadmon Holdings, Inc.kdmn-20170404xex99_1.htm



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)

 

 

 



 

 

 

 

 

 

 

 

 

Delaware

 

001-37841

 

27-3576929

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

 

450 East 29th Street

New  York, NY

 

10016

(Address of principal executive offices)

 

(Zip Code)

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:

 



 

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))


 

 

ITEM 8.01

Other Events.

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.





 

ITEM 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 



 

Exhibit No.

Description



 

99.1

Press Release, dated April 4, 2017, 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.

 



 

 

 

 

 

 

 

 

 

 

 

 

 

Kadmon Holdings, Inc.

 

 

 

Date: April 4, 2017

 

 

 

/s/ Konstantin Poukalov

 

 

 

 

Konstantin Poukalov

 

 

 

 

Executive Vice President, Chief Financial Officer