Current Report Filing (8-k)
August 24 2016 - 3:58PM
Edgar (US Regulatory)
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)
August 24, 2016 (August 18, 2016)
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified
in its charter)
Delaware
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0 - 27072
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52-0845822
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(state or other jurisdiction
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(Commission
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(I.R.S. Employer
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of incorporation)
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File Number)
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(Identification No.)
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1617 JFK Boulevard, Suite 500, Philadelphia, PA
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19103
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including
area code:
(215) 988-0080
1617 JFK Boulevard, Suite 500, Philadelphia,
PA 19103
(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):
¨
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 Aug 18, 2016, Hemispherx
Biopharma, Inc. (the “Company”) received approval of its New Drug Application (NDA) from Administracion Nacional de
Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the
Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The product will be
marketed by GP Pharm, Hemispherx’s commercial partner in Latin America.
A copy of the press release announcing
this approval is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
On August 20, 2016, the Company’s
Board of Directors appointed Stewart Appelrouth, the Company’s newly elected independent director, to the following Board
committees: Audit Committee, Compensation Committee, and Corporate Governance and Nominating Committee. Mr. Appelrouth also was
designated as the Audit Committee’s Financial Expert.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
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Description
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99.1
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Press release dated August 23, 2016 titled “Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the Argentine Republic”.
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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.
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HEMISPHERX BIOPHARMA, INC.
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August 24, 2016
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By:
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/s/ Thomas K. Equels
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Thomas K. Equels,
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President
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