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                                  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 1, 2009

                           HEMISPHERX BIOPHARMA, INC.
               (Exact Name of Registrant as Specified in Charter)

                           Delaware 0-27072 52-0845822
             (State or Other Jurisdiction (Commission (IRS Employer
               of Incorporation) File Number) Identification No.)

              1617 JFK Boulevard, Philadelphia, Pennsylvania, 19103
          (Address of Principal Executive Offices, including Zip Code)

       Registrant's telephone number, including area code: (215) 988-0080

                                 Not Applicable
          (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))

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Item 8.01 Other Events.

On December 1, 2009, the Company  issued a press release  announcing its receipt
of a Complete  Response Letter from the Food and Drug  Administration on its New
Drug Application for Ampligen(R).

A copy of the press release, dated December 1, 2009, is attached as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated by reference herein.


Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.                         Description

99.1                    Press  Release  dated  December  1, 2009  regarding
                        receipt of a Complete Response Letterfrom the Food
                        and Drug Administration.






                                   Signatures

         Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.


Date:  December 1, 2009

                                                 HEMISPHERX BIOPHARMA, INC.

                                                /s/ William A. Carter
                                                 ____________________________
                                                 William A. Carter, M.D.,
                                                 Chief Executive Officer






                                                                  Exhibit 99.1



Company/Investor Contact:
Dianne Will
Hemispherx Biopharma, Inc.

518-398-6222
ir@hemispherx.net

       Hemispherx Biopharma Receives Complete Response Letter from FDA on
          Ampligen(R) New Drug Application for Chronic Fatigue Syndrome
                     ...Outlines Additional Recommendations

Philadelphia,  PA - December 1, 2009 - Hemispherx  Biopharma,  Inc.  (NYSE Amex:
HEB) (the  "Company"  or  "Hemispherx"),  announced  that it received a Complete
Response Letter from the US Food and Drug Administration ("FDA") which describes
specific  additional   recommendations   related  to  the  Ampligen(R)  NDA.  In
accordance  with its  2008  "Complete  Response"  procedure,  the FDA  reviewers
determined  that they cannot  approve the  application  in its present  form and
provided specific recommendations to address the outstanding issues.  Hemispherx
is carefully  reviewing the Complete  Response letter and will seek an expedited
meeting with the FDA to discuss its  recommendations.  Management  is pleased to
have received  specific advice on the remaining issues and is looking forward to
making a thorough but expedited response its top priority, and plans to take all
appropriate steps to seek approval and commercialization of Ampligen(R).

Most notably,  the FDA stated that the two primary  clinical  studies  submitted
with the NDA did not provide  credible  evidence of efficacy of Ampligen(R)  and
recommends  at least one  additional  clinical  study which  shows a  convincing
effect and confirms safety in the target population.  The FDA indicated that the
additional study should be of sufficient size and sufficient duration (6 months)
and include  appropriate  monitoring  to rule out the  generation  of autoimmune
disease.  In  addition,  patients  in the study  should be on more than one dose
regimen,  including  at  least  300  patients  on  dose  regimens  intended  for
marketing. Finally, the additional study must incorporate both a well-controlled
QT interval study and pharmacokinetic evaluations.

Other items required by the FDA include certain  aspects of Non-Clinical  safety
assessment,   and  Product  Quality.  In  the  Non-Clinical  area,  the  FDA  is
recommending  that the Company  complete rodent  carcinogenicity  studies in two
species.  As part of the NDA  submission,  the Company had requested  that these
studies be  waived,  but the waiver  has not been  granted.  Certain  additional
non-clinical studies and additional data to support non-clinical studies already
submitted with the NDA are also  recommended by the FDA. Prior to the receipt of
the  Complete  Response  letter,  the Company  had  already  begun many of these
additional studies and the collection of the requested additional data.

Under the Product  Quality  section of the  Complete  Response  letter,  the FDA
recommends  that  the  Company  submit  additional  data  and  complete  various
analytical procedures.  The collection of these data and the completion of these
procedures is already part of the Company's  ongoing  Quality  Control,  Quality
Assurance  program  for  Ampligen(R)  manufacturing  under  cGMP  (current  Good
Manufacturing  Practice  Guidelines) and the manufacturing  enhancement  program
recently  undertaken by the Company and announced in a news release on September
16, 2009.

Finally,  the FDA  commented  on  Ampligen(R)  manufacturing  noting the need to
resolve outstanding  inspection issues at the facilities producing  Ampligen(R).
These include the Company facility  located in New Brunswick,  NJ and one of the
Company's third party manufacturing facilities  (Hollister-Stier  Laboratories).
The Company has been working to resolve these issues.

At this time the  Company's  management  has not  determined  the  impact of the
additional  recommendations  set forth in the  Complete  Response  letter on the
timelines  and  overall  cost of the  Ampligen(R)  program,  but  the  Company's
management  has made response to the issues and  satisfaction  of any additional
requirements  a top  priority.  The  Company  will  seek to meet with the FDA to
clarify any issues  identified in the Complete  Response letter and to work with
the  FDA  to  identify  the  most   expeditious  path  to  satisfaction  of  the
requirements for approval of the Ampligen(R) NDA.

About Hemispherx Biopharma
Chronic  Fatigue   Syndrome  is  an  enigmatic,   profoundly   debilitating  and
potentially  life-threatening  disease with which a new  retrovirus was recently
associated. Researchers are investigating the possible role of this virus in the
symptomatology of the disease.

Hemispherx  Biopharma,  Inc. is an  advanced  specialty  pharmaceutical  company
engaged in the  manufacture  and clinical  development  of new drug entities for
treatment of seriously  debilitating  disorders.  Hemispherx's flagship products
include  Alferon  N  Injection(R)  (FDA  approved  for a  category  of  sexually
transmitted diseases) and the experimental  therapeutics Ampligen(R) Oragens(R),
and Alferon LDO. Ampligen(R) and Oragens(R)  represent  experimental RNA nucleic
acids being developed for globally important debilitating diseases and disorders
of the immune system.  Hemispherx's platform technology includes large and small
agent components for potential  treatment of various  severely  debilitating and
life threatening diseases. Hemispherx has in excess of 50 patents comprising its
core intellectual property estate and a fully commercialized  product (Alferon N
Injection(R)).  The Company wholly owns and exclusively operates a GMP certified
manufacturing  facility in the United States for commercial  products.  For more
information please visit www.hemispherx.net.

Information  contained in this news release other than  historical  information,
should be considered  forward-looking and is subject to various risk factors and
uncertainties.  For  instance,  the  completion  of the NDA filing  process with
Ampligen(R)  and the receipt of a Complete  Response  Letter from the FDA do not
imply that the Company  will be able to  successfully  comply with any or all of
the  requirements  requested  in that  Letter or that the  product  will ever be
approved for  commercial  sale. In addition,  the  strategies  and operations of
Hemispherx involve risk of competition,  changing market  conditions,  change in
laws and  regulations  affecting  these  industries  and numerous  other factors
discussed in this release and in the Company's  filings with the  Securities and
Exchange  Commission.  Any  specifically  referenced  investigational  drugs and
associated  technologies of the Company (including  Ampligen(R),  Alferon(R) LDO
and Oragens(R))  are  experimental in nature and as such are not designated safe
and  effective  by a  regulatory  authority  for  general  use and  are  legally
available  only  through  clinical  trials with the  referenced  disorders.  The
forward-looking  statements  represent the Company's  judgment as of the date of
this release. The Company disclaims, however, any intent or obligation to update
these   forward-looking   statements.   Clinical   trials  for  other  potential
indications of the approved  biologic  Alferon N Injection(R)  do not imply that
the product  will ever be  specifically  approved  commercially  for these other
treatment indications.