hemispherx biopharma inc (HEB) Key Developments
U.S. District Court Judge Approves Hemispherx Biopharma's $2.7 Million Settlement
Jul 22 15
U.S. District Court judge approved a $2.75 million settlement that will resolve a class-action lawsuit brought by the shareholders of Hemispherx BioPharma, which alleged the company made 'material misrepresentations and omissions' regarding the status of a new drug application for its lead new drug candidate. The lawsuit - filed on behalf of investors who purchased or acquired Hemispherx stock between March 14, 2012 through December 20, 2012 - alleged Hemispherx representatives 'touted purportedly positive results from Ampligen's clinical trials'. The settlement includes a deadline of August 21, 2015 for shareholders to file claims.
Hemispherx Biopharma, Inc. Submits Application for Orphan Drug Designation to European Medicines Agency for Alferon N Injection®
Jul 15 15
Hemispherx Biopharma, Inc. announced that they have submitted an application for orphan drug designation to the European Medicines Agency (EMA) for Alferon N Injection®, an experimental therapeutic, to treat Middle East Respiratory Syndrome (MERS). The EMA has determined the application to be valid, and the Committee for Orphan Medicinal Products (COMP) has initiated the official review process. It is anticipated that the COMP will give an opinion on the application within the next 90 days. There are significant benefits for achieving Orphan Designation, including eligibility for grants from EU and Member State programs. Designated orphan medicines are assessed for marketing authorization centrally in the European Union with reductions/waivers in the fees and costs of the overall regulatory process. The designation allows companies to make a single application to the European Medicines Agency, resulting in a single opinion and a single decision from the European Commission, valid in all EU Member States. Authorized orphan medications, once commercially approved, receive benefits including ten years of complete protection from market competition with similar medicines.
Hemispherx Biopharma, Inc. Amends Restated and Amended By-Laws
Jun 24 15
On June 23, 2015, the Board of Hemispherx Biopharma, Inc. amended restated and amended By-Laws in accordance with a directive of Board of Directors to reduce the quorum, solely for the 2015 annual meeting of stockholders, from holders of a majority in voting power of the outstanding shares of stock to the holders of 40% in voting power of the outstanding shares of stock. The Board reduced the quorum, after consultation with the company's proxy advisory firm and due to low voter turnout experienced in the past.
Hemispherx Biopharma, Inc. Announces Preliminary Approval of Securities Class Action Settlement
Jun 4 15
Hemispherx Biopharma announced that the United States District Court for the Eastern District of Pennsylvania has granted preliminary approval of a settlement of the currently pending securities class action, Frater versus Hemispherx Biopharma, Inc. A final settlement hearing has been scheduled for July 22, 2015. The settlement will be paid from the company's insurance coverage and will not result in the payment of any funds by the company. The settlement expressly is not an admission of culpability by Hemispherx or any of the individual defendants.
Hemispherx Biopharma, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2015
May 28 15
Hemispherx Biopharma, Inc. reported earnings results for the first quarter ended March 31, 2015. For the quarter, total revenues were $36,000, compared to $76,000 for the same quarter ended March 31, 2014. Operating loss was $4.92 million, compared to an operating loss of $5.11 million for the same quarter ended March 31, 2014.