Altimmune (ALT Quick QuoteALT - Free Report) is developing its lead candidate, pemvidutide, a novel, investigational and peptide-based GLP-1/glucagon dual receptor agonist for treating obesity and metabolic dysfunction-associated steatohepatitis (MASH).

The company has made rapid progress with the development of pemvidutide, which has pushed up its stock price in recent months. A phase IIb IMPACT study is ongoing which is evaluating pemvidutide for the treatment of patients with biopsy-confirmed MASH.

Last month, Altimmune completed the end-of-phase II meeting with the FDA for the design of a phase III registrational program on pemvidutide for the treatment of obesity. The company remains on track to begin pivotal phase III studies on pemvidutide for obesity.

ALT stock has rallied 26.2% in the past month against the industry’s decrease of 0.9%.

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More on the Upcoming Phase III Design for Obesity

The registrational phase III program will consist of four double-blind, placebo-controlled phase III studies, each evaluating pemvidutide for the treatment of subjects with overweight and obesity over a period of 60 weeks.

The studies will investigate the safety and efficacy of different doses of pemvidutide (1.2 mg, 1.8 mg, and 2.4 mg) with the motive of approval for all three doses.

Last December, ALT reported positive top-line data from the phase II MOMENTUM study evaluating pemvidutide in obesity. Data from the study demonstrated dose-dependent reductions in mean body weight after 48 weeks of treatment with the drug.

Updates on ALT's Pemvidutide in MASH

In the third quarter of 2024, Altimmune completed patient enrollment in the phase IIb IMPACT study evaluating pemvidutide for treating MASH.

The study is investigating the efficacy and safety of pemvidutide in around 190 subjects with biopsy-confirmed MASH. The company is planning to report top-line efficacy data from pemvidutide phase IIb study in MASH in the second quarter of 2025.

Per management, a successful data readout from the IMPACT study will make pemvidutide the first MASH therapy to achieve both fibrosis improvement and significant weight loss at 24 weeks of treatment.

The FDA has already granted a Fast Track designation to pemvidutide for treating MASH.

ALT's Zacks Rank & Key Picks

Altimmune currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR Quick QuoteIMCR - Free Report) , Spero Therapeutics, Inc. (SPRO Quick QuoteSPRO - Free Report) and Castle Biosciences, Inc. (CSTL Quick QuoteCSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.1%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 22.4%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 40.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.