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Investing.com - Altimmune (NASDAQ:ALT) shares gained Thursday after the company announced positive topline data from its 24-week Phase 2b IMPACT trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH). The stock, currently trading at $3.61, has experienced significant volatility recently, with InvestingPro data showing a 48.65% decline over the past week.
The trial met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in 59.1% of patients receiving pemvidutide 1.2 mg and 52.1% at the 1.8 mg dose, versus 19.1% with placebo. H.C. Wainwright maintained its Buy rating and $12.00 price target on the stock following the announcement. According to InvestingPro, the broader analyst community remains bullish, with price targets ranging from $6 to $28 for this $293 million market cap company.
While fibrosis improvement without worsening of MASH was observed in 31.8% and 34.5% of patients in the 1.2 mg and 1.8 mg arms respectively, compared to 25.9% for placebo, these differences did not reach statistical significance. AI-based fibrosis reads and non-invasive tests showed significant improvements, providing evidence of anti-fibrotic activity.
Pemvidutide produced weight loss of up to 6.2% at 24 weeks, with a continued downward trajectory and no evidence of plateauing. The drug demonstrated favorable tolerability with less than 1% treatment discontinuation and no need for dose titration.
H.C. Wainwright noted these data support advancement to Phase 3 and strengthen the case for pemvidutide as a potential therapy for MASH, with expectations for a positive fibrosis outcome at 48 weeks. While the company maintains a strong financial position with more cash than debt and a healthy current ratio of 15.85, InvestingPro analysis suggests the stock is currently undervalued. Subscribers can access 12 additional ProTips and a comprehensive research report for deeper insights into Altimmune’s potential.
In other recent news, Altimmune, Inc. reported 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 fibrosis. The 24-week study involved 212 participants, and while improvements in fibrosis were noted, these were not statistically significant. A supplemental AI-based analysis did show significant reductions in fibrosis for some participants. Altimmune plans to discuss these results with the FDA as it prepares to advance to Phase 3 trials. Meanwhile, Citizens JMP analysts maintained their Market Outperform rating with a $25 price target for Altimmune, highlighting upcoming presentations on pemvidutide’s cardiovascular benefits. Stifel analysts also reiterated their Buy rating, setting an $18 price target, expressing optimism about pemvidutide’s potential in MASH treatment. Additionally, Altimmune has started a Phase 2 trial for pemvidutide in treating Alcohol Use Disorder (AUD), aiming to address significant treatment gaps in the U.S. This trial will evaluate the drug’s efficacy and safety over 24 weeks.
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