NasdaqGM:ALTBiotechs
Altimmune (ALT) Is Up 16.1% After FDA Breakthrough Nod For AI-Enhanced MASH Drug Trial – Has The Bull Case Changed?
Altimmune, Inc. recently announced that the FDA has granted Breakthrough Therapy Designation to pemvidutide, its balanced 1:1 glucagon/GLP-1 dual receptor agonist, for treating patients with metabolic dysfunction-associated steatohepatitis (MASH), based on encouraging Phase 2b IMPACT trial data and a completed end-of-phase 2 meeting aligning on a registrational Phase 3 program.
The planned Phase 3 trial will not only pursue biopsy-based endpoints for a potential accelerated approval but also...