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.
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(END) Dow Jones Newswires