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News Breaks
February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. 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, 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. 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
News For HEB From The Last 14 Days
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February 9, 2016
08:37 EDTHEBHemispherx exploring possible research program in Zika Virus
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February 3, 2016
08:46 EDTHEBHemispherx announces voluntary stock purchase plan
Hemispherx Biopharma announced a Voluntary Pay for Stock Plan. Hemispherx Biopharma is seeking to create ownership incentives as well as to provide additional cash for various operational activities. All members of Senior Management, all members of the board, and all employees volunteered to participate. Senior Management believes that this Plan creates significant shareholder value as the participants will voluntarily use up to 20% of their salaries to purchase stock from the company, creating long term incentives for them to reach corporate goals. In addition, the CEO/Chairman and President/CFO, will both voluntarily reduce their salaries further to a cumulative reduction of 50%. The plan goes into effect immediately.

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