Galmed Stock Jumps As FDA Signs Off Use Of Aramchol Meglumine In Late Stage NASH Trial

The FDA has agreed with Galmed Pharmaceuticals Ltd's GLMD plan to use Aramchol meglumine (instead of Aramchol free acid) in its Phase 3 ARMOR study without the need for additional studies other than planned limited pharmacology studies relating to Aramchol meglumine.
Aramchol meglumine is an improved compound using a salt form of Aramchol with higher water solubility than the free acid and an NCE patent protection valid until December 2034.
Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, liver targeted SCD1 modulator, developed as an oral therapy for nonalcoholic steatohepatitis (NASH) and fibrosis.
Price Action: GLMD shares are up 6.4% at $2.65 during the premarket session on the last check Monday.
Related content: Benzinga's Full FDA Calendar.