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): July 26, 2018

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

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. ¨

On July 26, 2018, ADMA Biologics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the Company received a target action date of October 25, 2018 under the Prescription Drug User Fee Act from the U.S. Food and Drug Administration (“FDA”) for the BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“BIVIGAM®”) Prior Approval Supplement (“PAS”) regulatory submission. The Company seeks approval to amend its FDA approved Biologics License Application for BIVIGAM® in the United States and ultimately relaunch BIVIGAM® once the PAS is approved.

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

(d) Exhibits

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.