* Says to respond to FDA in Q3
* FDA agrees to review new analyses of late-stage data
July 11 Hemispherx Biopharma Inc said
U.S. regulators agreed to accept for review new analyses of data
from a late stage trial of Ampligen, its experimental drug for
treating chronic fatigue syndrome.
The new analyses, if found sufficient, will be in lieu of an
additional study that the regulator had sought three years ago,
Hemispherx said in a statement.
The company said it plans to submit its response to the FDA
in the third quarter of 2012.
The specialty pharmaceutical company's stock soared as much
as 50 percent, rekindling hopes for the drug that has lost its
way for about five years. It was first filed for approval in
In November 2009, the U.S. Food and Drug Administration had
called for at least one additional clinical study of Ampligen,
including at least 300 patients on dose regimens intended for
Hemispherx's cash reserve, which was about $58.1 mln at the
end of 2009, fell to $3.7 million by the end of March this year,
according to a regulatory filing.
Hemispherx's shares were trading up 28 percent at 36 cents
on the NYSE Amex, after touching a high of 42 cents.