ADMA BIOLOGICS, INC. (NASDAQ:ADMA) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
ADMA Biologics, Inc. (the “Company”) has updated its investor presentation (the “Investor Presentation”) and a copy of the slides comprising the Investor Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Investor Presentation may also be accessed under the “Investor Relations” tab on the Company’s website at www.admabiologics.com.
In accordance with General Instruction B.2 on Form 8-K, the information set forth in this Item 7.01 and the Investor Presentation slides, attached to this report as Exhibit 99.1, are “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Please refer to Exhibit 99.1 for a discussion of certain forward-looking statements included therein and the risk and uncertainties related thereto.
On January 7, 2019, the Company issued a press release announcing that the Company has submitted responses to the U.S. Food and Drug Administration (“FDA”) Complete Response Letter received on December 19, 2018 for BIVIGAM®’s (Intravenous Immune Globulin [Human], 10%) (“BIVIGAM®”) Prior Approval Supplement (“PAS”). The Company anticipates receiving an acknowledgement letter from the FDA within 30 days, and plans to provide appropriate updates on the progress of the BIVIGAM® PAS review.
The full text of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
ADMA BIOLOGICS, INC. Exhibit
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To view the full exhibit click here
About ADMA BIOLOGICS, INC. (NASDAQ:ADMA)
ADMA Biologics, Inc. is a late-stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma-based biologics for the treatment and prevention of infectious diseases. The Company is engaged in the development and commercialization of human plasma and plasma-derived therapeutics. Its segments include Plasma Collection Centers, which includes its operations in Georgia; Research and Development, which includes its plasma development operations in New Jersey, and Corporate. Its targeted patient populations are immune-compromised individuals suffering from an underlying immune deficiency disorder or may be immune-suppressed for medical reasons. Its product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients at risk of contracting infectious diseases. Its intravenous immunoglobulin product candidate, RI-002, is intended for the treatment of primary immune deficiency disease.
