Altimmune, Inc. (NASDAQ: ALT) secured FDA Breakthrough Therapy Designation for its lead candidate pemvidutide in metabolic dysfunction‑associated steatohepatitis (MASH) on January 5 2026. The designation was granted based on 24‑week IMPACT Phase IIb data that demonstrated statistically significant MASH resolution without fibrosis worsening, along with marked reductions in liver fat and non‑invasive fibrosis markers.
Pemvidutide is a balanced 1:1 glucagon/GLP‑1 dual agonist that targets both metabolic and hepatic pathways. The Phase IIb results showed rapid MASH resolution and early antifibrotic activity, positioning pemvidutide as a potential first‑in‑class therapy in a field that has only one FDA‑approved drug—resmetirom—for moderate‑to‑advanced fibrosis and several GLP‑1 agonists for non‑cirrhotic MASH.
The Breakthrough designation is a de‑risking milestone that can accelerate development and review. Altimmune has already aligned with the FDA on the design of its Phase III registrational trial, which will evaluate multiple doses over 52 weeks with biopsy‑based endpoints. The company also holds Fast Track designations for MASH and alcohol‑use disorder, and pemvidutide is being studied for alcohol‑associated liver disease.
Altimmune remains a clinical‑stage biopharmaceutical company that is unprofitable but has a strong cash position, with cash reserves exceeding debt and a runway that supports the planned Phase III program. The company’s focus is on strengthening its foundation to advance pemvidutide through late‑stage development, and the Breakthrough designation is a key validation of that strategy.
CEO Jerry Durso said the designation “reinforces the promise of pemvidutide’s clinical profile and its potential to address significant unmet needs in a serious, progressive liver disease.” He emphasized that the milestone validates the company’s laser focus on advancing pemvidutide and signals confidence in the company’s ability to secure partnerships or non‑dilutive financing for late‑stage development.
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