Altimmune

At the Wells Fargo conference Altimmune presented pemvidutide as a franchise drug for MASH, alcohol use disorder (AUD) and alcohol-related liver disease (ALD). With $519 million in cash the company expects to fund the PERFORMA phase III MASH trial through data readout in 2029, but sees additional financing needs for a phase III AUD study and is pursuing non-dilutive options. Earlier phase II data showed signals of efficacy and good tolerability; Altimmune plans regulatory discussions (including with the FDA) to shape the AUD phase III. » Więcej na de.investing.com

Altimmune has initiated the global, randomized, double‑blind, placebo‑controlled phase‑3 PERFORMA study evaluating pemvidutide in patients with MASH and moderate to advanced fibrosis. Cohort 1 includes about 990 patients and targets an accelerated approval; the primary endpoint is biopsy‑assessed resolution of MASH and improvement in fibrosis at 52 weeks. A second cohort of roughly 800 patients is planned to expand the safety database; 52‑week data are expected in 2029. Pemvidutide is a dual glucagon and GLP‑1 agonist with FDA Fast Track and Breakthrough Therapy designation; the study incorporates the FDA‑qualified AI tool AIM‑MASH AI Assist to standardize histologic assessments. » Więcej na de.investing.com

Altimmune shares rose about 11.5% in premarket trading after positive topline results from the Phase‑2 RECLAIM study. Pemvidutid (2.4 mg) reduced heavy drinking days by a statistically significant 1.45 days versus placebo over 24 weeks and also met FDA‑relevant secondary endpoints such as a two‑level reduction in WHO risk categories and achieving zero heavy drinking days. Pemvidutid is a dual glucagon/GLP‑1 agonist with Fast Track status for AUD and Breakthrough Therapy designation for MASH; Altimmune plans an end‑of‑Phase‑2 meeting with the FDA and is preparing Phase‑3 activities, including the PERFORMA study start targeted for Q3 2026. The stock traded at $3.30, well below the 52‑week high of $6.44 but above the year low of $2.56. » Więcej na de.investing.com