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GAITHERSBURG, Md. - Altimmune, Inc. (NASDAQ:ALT), whose stock has surged over 13% in the past week according to InvestingPro data, announced Thursday that its Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint, with up to 59.1% of participants achieving MASH resolution without worsening of fibrosis.
The 24-week IMPACT trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3. In an intent-to-treat analysis, participants receiving pemvidutide at 1.2 mg and 1.8 mg doses showed significantly higher rates of MASH resolution (59.1% and 52.1%, respectively) compared to placebo (19.1%). The company, currently valued at $625 million, maintains a strong financial position with more cash than debt on its balance sheet and a healthy current ratio of 15.85, as reported by InvestingPro.
While improvements in fibrosis without worsening of MASH were observed (31.8% at 1.2 mg and 34.5% at 1.8 mg versus 25.9% for placebo), these differences were not statistically significant. However, a supplemental AI-based analysis showed significant fibrosis reduction, with 30.6% of participants on the 1.8 mg dose achieving at least 60% reduction in fibrosis compared to 8.2% on placebo.
The drug also demonstrated weight loss effects of 5.0% and 6.2% at the 1.2 mg and 1.8 mg doses respectively, compared to 1.0% with placebo. Liver fat was reduced by 58.0% and 62.8% in the treatment groups versus 16.2% in the placebo group.
Pemvidutide showed favorable tolerability with less than 1.2% of participants discontinuing treatment due to adverse events, compared to 2.4% in the placebo group. No serious adverse events related to the medication were reported.
"The combination of MASH resolution and weight loss achieved at only 24 weeks is unique among drugs in development for MASH," said Dr. Mazen Noureddin, Professor of Medicine at Houston Methodist Hospital, according to the company’s press release.
Altimmune plans to meet with the FDA in the fourth quarter of 2025 to discuss progression to Phase 3 trials. Five analysts have recently revised their earnings estimates upward, with price targets ranging from $6 to $28 per share. For deeper insights into Altimmune’s financial health and growth prospects, including 13 additional ProTips and comprehensive valuation metrics, check out the full research report available on InvestingPro.
In other recent news, Altimmune has reported its first-quarter 2025 financial results, revealing a narrower-than-expected loss. The company’s earnings per share (EPS) were -$0.26, surpassing analyst expectations of -$0.38, with revenue for the quarter standing at $5 million. Altimmune has also initiated the Phase 2 RECLAIM trial to evaluate pemvidutide’s efficacy for Alcohol Use Disorder (AUD), enrolling subjects at approximately 15 U.S. sites. Additionally, the company is preparing for a pivotal Phase 2b IMPACT data readout for Metabolic Associated Steatohepatitis (MASH) expected later this month, which is anticipated to be a significant event for the company.
Analysts have been active in their evaluations of Altimmune. Citizens JMP reiterated a Market Outperform rating with a $25 price target, while Stifel maintained a Buy rating with an $18 target. Piper Sandler also reaffirmed its Overweight rating, citing the potential for pemvidutide to close the valuation gap with competitors in the NASH market. The company’s management has engaged in discussions highlighting the potential of pemvidutide in the developing MASH market, noting its potential for rapid reductions in liver fat and improvements in cardiovascular risk.
Altimmune’s ongoing research and development efforts continue to focus on pemvidutide, which is being studied for various conditions, including MASH, obesity, and alcohol liver disease (ALD). The company has also entered into a credit facility with Hercules Capital for up to $100 million, providing financial flexibility to support its continued development programs. The anticipated release of Phase 2b IMPACT data in MASH is seen as a key catalyst for the company’s stock performance.
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