Altimmune Above Water on FDA Nod

Altimmune, Inc. (NASDAQ: ALT) shares gained Tuesday. The company, a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder (AUD). Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs.RECLAIM, a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling. Approximately 100 patients will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days, with key secondary endpoints including the proportion of subjects achieving a two-level reduction in World Health Organization (WHO) risk drinking level and absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake. The trial began enrolling in May 2025.Despite an estimated prevalence of AUD in more than 28 million adults in the U.S. alone, the scarcity of effective treatment options has created a sizeable treatment gap in AUD, with only 2% being treated with medication today,” said CEO Vipin K. Garg. “Currently approved therapies have shown limited effectiveness and fail to adequately address the comorbidities of AUD, such as hepatic steatosis, hyperlipidemia and hypertension, or other comorbidities of obesity from which individuals with AUD often suffer.”ALT shares gathered 12 cents, or 3.2%, to begin Tuesday at $3.68.