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. » Mere på 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. » Mere på 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. » Mere på de.investing.com

Altimmune reported Q1 2026 EPS of -$0.18, beating the estimate of -$0.24. Net loss was $22.6 million, and cash on hand stood at $535 million after a $225 million capital raise. Despite the upside surprise, the stock fell about 4.9% in premarket trading; the company plans a phase III trial of pemvidutid for MASH in the second half of 2026 and expects Q2 EPS of -$0.15. » Mere på de.investing.com

Altimmune completed a public offering raising about $225 million, consisting of 64.25 million common shares and 10.75 million pre‑funded warrants with accompanying warrants. The securities were issued at $3.00 and $2.999 each, respectively; the warrants are immediately exercisable and expire after five years or 45 days following a positive phase‑3 announcement for Pemvidutid in MASH. The proceeds will finance the planned phase‑3 study of Pemvidutid and working capital; the study is slated to start in the second half of 2026. The round was led by Deep Track Capital, with participation from TCGX, Viking Global Investors and RA Capital Management; Altimmune shares traded near their 52‑week low before the transaction. » Mere på de.investing.com