ALT Stock Up 17% After Pemvidutide Gets FDA Breakthrough Tag for MASH

Core Insights - Altimmune (ALT) has received FDA Breakthrough Therapy Designation for pemvidutide, a dual receptor agonist aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [1][5] - The Breakthrough Therapy designation is designed to expedite the development and review of therapies for serious diseases with unmet medical needs [2] - Following the announcement, ALT's shares increased by 16.52%, although they have seen a 44% decline over the past year compared to a 1.4% rise in the industry [2] Study Data - The Breakthrough Therapy status is supported by 24-week data from the phase IIb IMPACT study, which showed significant MASH resolution without worsening fibrosis and early improvements in liver health markers [3][5] - In December, 48-week data from the IMPACT study indicated continued significant improvements in liver health markers and weight loss at the 1.8 mg dose [6] - Altimmune confirmed alignment with the FDA to advance pemvidutide into a phase III study for MASH patients with moderate to severe liver fibrosis, expected to begin in 2026 [7] Additional Developments - Pemvidutide is also being developed for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD) in mid-stage studies, with Fast Track designations already granted for MASH and AUD [8]