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 19, 2018

 

ADMA BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
     
Delaware 001-36728 56-2590442

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.) 

   
465 State Route 17, Ramsey, New Jersey 07446
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (201) 478-5552

 

 
(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):

 

o 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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 ý

 

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. ¨

 

 

 

 

 

Item 8.01              Other Events.

 

On December 19, 2018, ADMA Biologics, Inc., a Delaware corporation, issued a press release announcing that the U.S. Food and Drug Administration has issued a Complete Response Letter for the drug substance Prior Approval Supplement (“PAS”) submission for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“BIVIGAM®”) and previously approved the drug product PAS submission for BIVIGAM®.

 

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

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
   
99.1

ADMA Biologics, Inc. Press Release, dated December 19, 2018. 

 

 

 

 

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.

 

December 19, 2018 ADMA Biologics, Inc.
   
   
  By:  /s/ Brian Lenz
    Name:  Brian Lenz
    Title: Executive Vice President and Chief Financial Officer