ALT Stock Up 17% After Pemvidutide Gets FDA Breakthrough Tag for MASH

Altimmune ALT announced that the FDA has granted Breakthrough Therapy Designation to its lead pipeline candidate, pemvidutide, a novel, investigational GLP-1/glucagon dual receptor agonist, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH).

MASH is a progressive liver disease that often leads to liver inflammation, fibrosis, obesity, diabetes, and metabolic disorders.

The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs.

ALT’s shares rose 16.52% in response.

Over the past year, ALT’s shares have declined 44% against the industry’s 1.4% rise.

Breakthrough Tag Based on Altimmune’s IMPACT Study Data

The Breakthrough Therapy status was supported by 24-week data from the phase IIb IMPACT study announced in June. The data demonstrated statistically significant MASH resolution without worsening fibrosis, along with early improvements in liver fat, fibrosis and inflammation markers.

Altimmune announced 48-week data from the IMPACT study in December. The data showed that pemvidutide delivered statistically significant improvements versus placebo across key non-invasive fibrosis and liver health markers, with continued antifibrotic improvement from week 24 and additional weight loss at the 1.8 mg dose without plateauing.

In December 2025, Altimmune confirmed alignment with the FDA and agreed to advance pemvidutide into a phase III study for MASH patients with moderate to severe liver fibrosis. The study is expected to begin in 2026.

More on ALT’s Pemvidutide

Beyond MASH, pemvidutide is also being developed to treat alcohol use disorder (AUD), and alcohol-associated liver disease (ALD) in mid-stage studies.

The FDA has already granted Fast Track designations to pemvidutide for the treatment of MASH and AUD.

Altimmune’s Zacks Rank & Other Stocks to Consider

Altimmune currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD, and Indivior INDV, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 adjusted EPS have increased from $7.81 to $8.08. Shares of ANIP have surged 44.6% over the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, 2026 EPS estimates for CorMedix have risen from $2.49 to $2.88. Shares of CRMD have surged 18.3% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, estimates for Indivior’s earnings per share for 2026 have risen to $2.85 from $2.60. Indivior stock has rallied 192.3% over the past year.

Indivior’s earnings beat estimates in three of the trailing four quarters and were in line in the remaining quarter, with the average surprise being 68%.

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This article originally published on Zacks Investment Research (zacks.com).

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