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News Breaks
August 6, 2014
08:38 EDTCYTXCytori Therapeutics downgraded to Hold from Buy at Ascendiant
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October 23, 2014
09:04 EDTCYTXOn The Fly: Pre-market Movers
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October 22, 2014
18:19 EDTCYTXCytori Therapeutics receives FDA approval to resume ATHENA trial enrollment
Cytori Therapeutics has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials. The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trials’ internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients. Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytori’s submission was received on October 22.

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