Benzinga | Aug 2, 2021 09:26AM EDT

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 (NASDAQ: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.