New York – November 3, 2009 – Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating Philadelphia, Pennsylvania-based Hemispherx Biopharma, Inc. (“Hemispherx” or the “Company”) (AMEX: HEB) for potential violations of the federal securities laws. Investors who purchased Company securities since May 2009 may be affected, including purchasers in Hemispherx’s common stock offerings.
On May 26, 2009, the Company disclosed that the U.S. Food and Drug Administration (“FDA”) had advised the company that “[the FDA] may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug application for Ampligen..., a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome.” The Company further stated as follows regarding the reason for the delay:
Reason for possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company’s development plan for Ampligen (r) continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.
On November 2, 2009, Hemispherx disclosed that it “plans to complete queries from the FDA regarding its New Drug Application (NDA) for Ampligen (R), an experimental therapeutic, during November and December 2009. In the same disclosure, the Company stated that “several outstanding NDA items, requiring Hemispherx responses existed at the time of the FDA delay….” Additionally, the November 2, 2009 press release disclosed that between March 9, 2009 and September 15, 2009, the Company had issued six new reports to the FDA and that it plans to submit four additional reports to the FDA in November and December 2009.
On November 2, 2009, Hemispherx’s common stock declined by $.12 per share, about 8.2%, to close at $1.33 per share.
If you purchased Hemispherx publicly traded securities and would like to discuss our investigation, please e-mail us at mail@kaplanfox.com or contact:
Frederic S. Fox
Joel B. Strauss
Donald R. Hall
Hae Sung Nam
Jeffrey P. Campisi
Pamela A Mayer
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail address: mail@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California 94104
(415) 772-4700
Fax: (415) 772-4707
E-mail address: mail@kaplanfox.com
