Altimmune announces successful completion of End-of-Phase 2 meeting

Altimmune (ALT) announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration, FDA, and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity. “Our interactions with the FDA regarding the Phase 3 development program have been incredibly productive, and this regulatory alignment represents a major accomplishment for our team,” said Vipin K. Garg, Ph.D., Chief Executive Officer of Altimmune. “As the metabolic landscape continues to evolve, we believe that the ability of a drug to address both obesity and its underlying comorbidities will become increasingly important, and we are confident that this is where pemvidutide has an opportunity to excel. Achieving this regulatory milestone is especially important as we advance our partnering efforts, approach the data readout from our Phase 2b IMPACT Trial in MASH and prepare IND submissions for additional indications.”