Key Developments: Hemispherx Biopharma Inc (HEB)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
Levi & Korsinsky Notifies Investors With Losses On Their Investment In Hemispherx Biopharma, Inc. Of Class Action Lawsuit And Deadline Of March 5, 2013 To Seek Lead Plaintiff Position
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Eastern District of Pennsylvania on behalf of investors who acquired Hemispherx Biopharma, Inc. (Hemispherx or the Company) stock between March 19, 2012 and December 17, 2012. The Complaint asserts violations of the federal securities laws against Hemispherx and its officers and directors for issuing false and misleading information about its lead drug candidate Ampligen. Specifically, that Hemispherx misstated the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen's clinical trials. On December 18, 2012, the FDA published a staff report concluding that the Company's studies were ill-defined and invalid with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, it is difficult to draw conclusions regarding potential safety signals," but the review identified nine potential safety concerns associated with Ampligen. The Complaint alleges that as a result of this adverse information, Hemispherx stock price dropped from $0.64 to $0.37. Full Article
Cohen Milstein Sellers & Toll PLLC Continues To Investigate Hemispherx Biopharma Inc Following FDA`s Rejection Of Ampligen New Drug Application
Cohen Milstein Sellers & Toll PLLC announced that it is conducting an investigation to determine whether Hemispherx Biopharma, Inc. (Hemispherx or the Company) and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. A class action lawsuit was filed in the U.S. District Court Eastern District of Pennsylvania by another law firm on behalf of purchasers of the common stock of Hemispherx Biopharma, Inc. between March 19, 2012 and December 17, 2012, inclusive (the Class Period). The complaint alleges that Hemispherx and certain of its officers and directors (Defendants) made false and misleading statements regarding the safety and efficacy of Ampligen, and also misrepresented and/or failed to disclose that Hemispherx could not demonstrate the requisite safety and efficacy of Ampligen because its clinical trials were not properly designed. The Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ampligen in 2007. On February 4, 2013, Hemispherx announced the receipt of a Complete Response letter from the FDA regarding Ampligen, which conveyed that the FDA`s review of the Ampligen application was complete and that it would not approve the application in its present form. Full Article
Hemispherx Biopharma Inc Receives Complete Response Letter From FDA on Ampligen New Drug Application For Chronic Fatigue Syndrome
Hemispherx Biopharma Inc announced that it received a Complete Response Letter from the US Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for Ampligen for Chronic Fatigue Syndrome (CFS). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its Complete Response Letter (CRL), the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. In the two pivotal clinical studies that form the basis of approval for Ampligen, Hemispherx believes that the primary efficacy endpoints were met and that they showed a statistically significant improvement (i.e., with a p-value of 0.05 or less). The FDA and Hemispherx do agree that in clinical study AMP-502, the primary endpoint was met (p=0.02). Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the Office of New Drugs in the FDA's Center for Drug Evaluation and Research regarding the Agency's decision. Full Article
Levi & Korsinsky Commences Lawsuit Against Hemispherx Biopharma Inc
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Eastern District of Pennsylvania on behalf of investors who acquired Hemispherx Biopharma Inc stock between March 19, 2012 and December 17, 2012. The Complaint asserts violations of the federal securities laws against Hemispherx and its officers and directors for issuing false and misleading information about its lead drug candidate Ampligen. Specifically, that Hemispherx misstated the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen's clinical trials. On December 18, 2012, the FDA published a staff report concluding that the Company's studies were "ill-defined and invalid" with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, "it is difficult to draw conclusions regarding potential safety signals," but the "review identified nine potential safety concerns associated with Ampligen." The Complaint alleges that as a result of this adverse information, Hemispherx stock price dropped from $0.64 to $0.37. Full Article
Robbins Arroyo LLP Announces Filing Of Securities Fraud Class Action Lawsuit Against Hemispherx Biopharma Inc
Shareholder rights attorneys at Robbins Arroyo LLP announced that purchasers of Hemispherx Biopharma Inc have filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania. The complaint alleges the Company and certain of its officers and directors violated the Securities Exchange Act of 1934 between March 19, 2012 and December 17, 2012 (the class period). Hemispherx is a biopharmaceutical company that focuses on the development of new drug therapies to treat viral and immune based chronic disorders. The complaint alleges that the Company issued a series of materially false and misleading statements to investors regarding the safety and efficacy of Ampligen, a drug intended as a treatment for Chronic Fatigue Syndrome. Specifically, the complaint alleges that Hemispherx misrepresented and failed to disclose that Ampligen did not meet safety and efficacy requirements because its clinical trials were not properly designed. Full Article
Cohen Milstein Sellers & Toll PLLC Announces Investigation Of Hemispherx Biopharma Inc
Cohen Milstein Sellers & Toll PLLC announced that it is conducting an investigation to determine whether Hemispherx Biopharma Inc and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. A class action lawsuit was filed in the U.S. District Court Eastern District of Pennsylvania by another law firm on behalf of purchasers of the common stock of Hemispherx Biopharma Inc ( between March 19, 2012 and December 17, 2012, inclusive (the Class Period). The complaint alleges that Hemispherx and certain of its officers and directors (Defendants) made false and misleading statements regarding the safety and efficacy of Ampligen, and also misrepresented and/or failed to disclose that Hemispherx could not demonstrate the requisite safety and efficacy of Ampligen because its clinical trials were not properly designed. The Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ampligen in 2007. In 2009, the FDA rejected the application, stating that the clinical studies for the drug “did not provide credible evidence of efficacy of Ampligen” in patients with CFS and recommending that the Company conduct additional studies of the drug. Full Article
Pomerantz Grossman Hufford Dahlstrom & Gross LLP Announces Class Action Lawsuit Against Hemispherx Biopharma Inc
Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Hemispherx Biopharma Inc ("Hemispherx" or the "Company") and certain of its officers. The class action filed in United States District Court, Eastern District of Pennsylvania, on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Hemispherx between March 22, 2012 and December 17, 2012, both dates inclusive (the "Class Period"). This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Full Article
Ryan & Maniskas, LLP Announces Class Action Lawsuit Against Hemispherx Biopharma Inc
Ryan & Maniskas, LLP announced that a class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania on behalf of purchasers of Hemispherx Biopharma Inc common stock during the period between March 19, 2012 and December 17, 2012, inclusive. The Complaint alleges that throughout the Class Period, the Company made a host of materially false and misleading statements regarding the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen's clinical trials. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times. On December 18, 2012, the FDA published an FDA staff report concerning Ampligen's safety and efficacy. Specifically, the report concluded that the Company's studies were 'ill-defined and invalid' with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, 'it is difficult to draw conclusions regarding potential safety signals,' but the 'review identified nine potential safety concerns associated with Ampligen'. On this news, Hemispherx shares declined $0.276 per share or nearly 43%, to close at $0.368 per share on December 18, 2012. Full Article
Gainey & McKenna Announces Securities Fraud Class Action Lawsuit Against Hemispherx Biopharma Inc
Gainey & McKenna announced that a class action lawsuit has been filed in the United States District Court for the Eastern District of Pennsylvania on behalf of investors who acquired Hemispherx Biopharma Inc securities between March 19, 2012 and December 17, 2012, inclusive (the Class Period), alleging violations of the Securities Act of 1934 against the Company, certain of its officers and directors. The Complaint asserts violations of the federal securities laws against Hemispherx and its officers and directors for issuing false and misleading information about its lead drug candidate Ampligen. Specifically, that Hemispherx misstated the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen's clinical trials. On December 18, 2012, the FDA published a staff report concluding that the Company's studies were 'ill-defined and invalid' with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, 'it is difficult to draw conclusions regarding potential safety signals', but the 'review identified nine potential safety concerns associated with Ampligen'. The Complaint alleges that as a result of this adverse information, Hemispherx stock price dropped and investors have been damaged. Full Article
Pomerantz Grossman Hufford Dahlstrom & Gross LLP Announces Class Action Lawsuit Against Hemispherx Biopharma Inc
Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Hemispherx Biopharma, Inc. (Hemispherx or the Company) and certain of its officers. The class action filed in United States District Court, Eastern District of Pennsylvania, and docketed under 2:12-cv-07152-WY on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Hemispherx between March 19, 2012 and December 17, 2012, both dates inclusive (the Class Period). This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. Full Article
Hemispherx says FDA rejects fatigue drug application
- Hemispherx Biopharma Inc said U.S. regulators had declined to approve its new drug application for Ampligen, its experimental drug for treating chronic fatigue syndrome, five years after the company first filed for the drug's approval.
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