"Of the 28 million Americans with AUD, over 6 million have progressed to ALD, a condition for which there are no approved treatments and few in development," said Dr. Loomba. "Alcohol-related liver mortality is highest in patients with comorbid obesity, highlighting the urgent need for a liver-directed therapy that can also drive weight loss. The robust reductions in body weight, liver fat and VCTE and the low rates of adverse event discontinuation in the recently completed IMPACT Phase 2b MASH trial suppor ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Altimmune, Inc. and its officers or directors following the release of trial results that led to a significant drop in the company's stock price [1][3]. Group 1: Company Overview - Altimmune, Inc. is a publicly traded company on NASDAQ under the ticker symbol ALT [1]. - The company recently announced "topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH)" [3]. Group 2: Trial Results - The trial results were described as "positive," but the key efficacy endpoint showed fibrosis improvement rates of 31.8% and 34.5% for pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 25.9% for placebo, with differences not being statistically significant [3]. - Following the announcement of these results, Altimmune's stock price fell by $4.10 per share, representing a decline of 53.18%, closing at $3.61 per share on June 26, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is conducting an investigation on behalf of investors regarding potential securities fraud or other unlawful practices by Altimmune and its management [1]. - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered numerous multimillion-dollar damages awards for victims of securities fraud [4].

Core Viewpoint - Altimmune, Inc. is under investigation for potential securities fraud following the release of mixed results from a clinical trial, which led to a significant drop in its stock price [1][2]. Group 1: Investigation and Legal Context - Pomerantz LLP is investigating claims on behalf of investors of Altimmune regarding possible securities fraud or unlawful business practices by the company and its officers or directors [1]. - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud [3]. Group 2: Clinical Trial Results and Market Reaction - On June 26, 2025, Altimmune announced "topline results" from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), describing the results as "positive" [2]. - The trial reported fibrosis improvement rates of 31.8% and 34.5% for pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 25.9% for placebo, with the differences not being statistically significant [2]. - Following the announcement, Altimmune's stock price fell by $4.10, or 53.18%, closing at $3.61 per share on the same day [2].

Core Insights - Altimmune, Inc. released topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease [1] Group 1: Trial Details - The Phase 2b trial included 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses, or placebo for 24 weeks [2] - Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment [3] Group 2: Efficacy Results - In an intent-to-treat (ITT) analysis, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% for pemvidutide 1.2 mg, 52.1% for 1.8 mg, and 19.1% for placebo (p< 0.0001 for both doses) [3] - The effects on fibrosis improvement without worsening of MASH were 31.8% for pemvidutide 1.2 mg, 34.5% for 1.8 mg, compared to 25.9% for placebo, although these differences were not statistically significant [4] Group 3: Analyst Ratings - HC Wainwright reiterated a Buy rating for Altimmune with a price forecast of $12, believing the data supports advancing pemvidutide to Phase 3 and strengthens its case as a potential best-in-class therapy [5] - Conversely, William Blair maintained a Market Perform rating, citing "underwhelming" results and concerns about demonstrating significant fibrosis improvement at the 48-week mark [6] Group 4: Stock Performance - ALT stock is trading lower by 1.80% to $3.545 at last check [7]

Group 1 - Altimmune, Inc. (NASDAQ: ALT) is competing in the metabolic disease drug development sector against major pharmaceutical companies like Novo Nordisk (NVO) and Eli Lilly (LLY) [1] - The article highlights the significance of innovative companies in developing breakthrough therapies and pharmaceuticals that have potential acquisition catalysts [1] Group 2 - The author of the article is a full-time healthcare investor with a focus on biotech and life-saving therapies, emphasizing the importance of understanding the market dynamics in this sector [1]

ATLANTA, June 26, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Altimmune, Inc. (“Altimmune” or the “Company”) (NASDAQ: ALT) complied with federal securities laws. On June 26, 2025, Altimmune announced topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH), revealing that the trial did not demonstrate statistical significance for the endpoint of improving fibrosis while not worsening MASH. Following this news, the pri ...

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Altimmune (ALT) Conference Call Summary - June 26, 2025 Company and Industry Overview - **Company**: Altimmune, Inc. - **Industry**: Biopharmaceuticals, specifically focusing on treatments for metabolic dysfunction associated with steatohepatitis (NASH) Key Points and Arguments 1. **IMPACT Phase 2b Trial Results**: The conference call focused on the top-line results from the IMPACT Phase 2b trial of pembidutide in NASH, highlighting significant findings related to NASH resolution and fibrosis improvement [7][8][29] 2. **Trial Design**: A total of 212 subjects were enrolled with three treatment arms: placebo, pembidutide 1.2 mg, and pembidutide 1.8 mg, administered weekly for 48 weeks. The primary endpoints were assessed via liver biopsy at 24 weeks [10][11] 3. **NASH Resolution Rates**: Pembidutide achieved a NASH resolution rate of 59.1% compared to 19.1% for placebo, indicating a highly significant treatment effect [14][30] 4. **Fibrosis Improvement**: Although positive trends in fibrosis improvement were observed, statistical significance was not achieved. The absolute fibrosis improvement was 34.5% for the 1.8 mg dose, similar to other candidates [17][29] 5. **Weight Loss**: Significant weight loss of up to 6.2% was reported at the 1.8 mg dose at 24 weeks, with the potential for greater weight loss with a higher dose of 2.4 mg [23][30] 6. **Safety and Tolerability**: The trial demonstrated a low discontinuation rate due to adverse events, with rates less than placebo, indicating a favorable safety profile [25][30] 7. **AI-Based Analyses**: AI-based readings showed significant reductions in fibrosis, suggesting that longer treatment durations could yield statistically significant results for fibrosis improvement [19][29] 8. **Regulatory Pathway**: The data positions pembidutide favorably for Phase III success and potential regulatory approval, with expectations of achieving statistical significance in both NASH resolution and fibrosis improvement [29][30] Additional Important Content 1. **Placebo Response**: The conference discussed the high placebo response rates observed in the trial, which were attributed to the methodology used in biopsy readings. The team is considering alternative methods for Phase III to mitigate this response [46][52] 2. **Future Trials**: Plans for Phase III trials are underway, with discussions about potentially using a higher dose of 2.4 mg and innovative designs to accelerate enrollment [84][86] 3. **Comparative Positioning**: Pembidutide is positioned as a highly differentiated product in the NASH market due to its combination of NASH resolution, weight loss, and favorable tolerability compared to other treatments like semaglutide and tirzepatide [96][98] 4. **Market Potential**: The call emphasized the high prevalence of NASH and the need for effective treatments, positioning pembidutide as a potential foundational therapy in this space [38][76] This summary encapsulates the critical findings and discussions from the Altimmune conference call, providing insights into the company's progress and future directions in the treatment of NASH.

IMPACT Phase 2b MASH Trial - Topline Results Pemvidutide: Designed to be the Treatment of Choice for Liver and Cardiometabolic Diseases June 26, 2025 Company Confidential Forward-looking statements Safe-Harbor Statement This presentation has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future ...

Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), demonstrating significant MASH resolution and weight loss at 24 weeks [2][4][5] Study Results - The Phase 2b trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks [3][10] - In an intent-to-treat (ITT) analysis, MASH resolution without worsening of fibrosis was achieved in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 19.1% for placebo (p< 0.0001) [3][7] - Fibrosis improvement without worsening of MASH was observed in 31.8% and 34.5% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 25.9% for placebo [3][7] - Weight loss at 24 weeks was 5.0% for the 1.2 mg group and 6.2% for the 1.8 mg group, compared to 1.0% in the placebo group (p< 0.001) [3][7] - Liver fat reductions of 58.0% and 62.8% were achieved in participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 16.2% in the placebo group (p< 0.001) [7][8] Safety and Tolerability - Pemvidutide demonstrated potentially best-in-class tolerability, with less than 1% treatment discontinuations due to adverse events [2][4] - Adverse events leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 2.4% in the placebo group [3][7] Future Outlook - The company anticipates a successful End of Phase 2 meeting with the FDA in the fourth quarter of 2025, enabling rapid progression to Phase 3 [5][4] - The ongoing IMPACT trial is expected to provide a final readout in the fourth quarter of 2025 [10]