Form 8-K

 

 

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): January 26, 2015

 

 

ANTARES PHARMA, INC.

(Exact name of registrant specified in its charter)

 

 

 

Delaware   1-32302   41-1350192

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(I.R.S. Employer

Identification No.)

100 Princeton South, Suite 300, Ewing, NJ   08628
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone, including area code: (609) 359-3020

 

 

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))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01 Regulation FD Disclosure.

On January 26, 2015, Antares Pharma, Inc. issued a press release announcing that that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies.

The full text of such press release is included as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

   

Description

99.1    Press Release, dated January 26, 2015, issued by Antares Pharma, Inc.

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.

 

ANTARES PHARMA, INC.
Date:  January 26, 2015 By:

/s/ James E. Fickenscher

Name: James E. Fickenscher
Title: Senior Vice President, Chief Financial Officer

EXHIBIT INDEX

Exhibit

 

Exhibit No.

   

Description

99.1    Press Release, dated January 26, 2015, issued by Antares Pharma, Inc.