Galmed Shares Up After FDA Agrees With Plan on Study
August 02 2021 - 8:36AM
Dow Jones News
By Michael Dabaie
Galmed Pharmaceuticals Ltd. said the U.S. Food and Drug
Administration agreed with its plan to use Aramchol meglumine in
its Phase 3 ARMOR study, sending shares higher in premarket
trading.
The clinical-stage biopharmaceutical company for liver,
metabolic and inflammatory diseases said the FDA agreed that Galmed
can proceed with its proposed clinical studies with Aramchol
meglumine in lieu of Aramchol free acid without the need to repeat
nonclinical and clinical studies.
Shares were up 8% to $2.70 in premarket trading.
Galmed said Aramchol meglumine is an improved compound using a
salt form of Aramchol that has significantly greater water
solubility than the free acid. Aramchol meglumine contains the same
active pharmaceutical ingredient called Aramchol, an oral therapy
for the treatment of nonalcoholic steatohepatitis and fibrosis.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
August 02, 2021 08:30 ET (12:30 GMT)
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