This section highlights FDA-related milestones and regulatory updates for drugs developed by Altimmune (ALT).
Over the past two years, Altimmune has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
pemvidutide and Pemvidutide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
pemvidutide - FDA Regulatory Timeline and Events
pemvidutide is a drug developed by Altimmune for the following indication: for the treatment of obesity and MASH.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- pemvidutide
- Announced Date:
- July 9, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD).
AI Summary
Altimmune, Inc. has enrolled the first patient in its RESTORE Phase 2 trial studying pemvidutide in people with Alcohol-Associated Liver Disease (ALD). Pemvidutide, a novel dual GLP-1/glucagon receptor agonist, is designed to help improve liver health and promote weight loss. The trial is a randomized, placebo-controlled study that will include about 100 patients across 34 sites. Participants will receive either 2.4mg of pemvidutide or a placebo over 48 weeks.
The main goal of the RESTORE trial is to observe changes in liver stiffness after 24 weeks using a non-invasive test called vibration controlled transient elastography (VCTE). Secondary measures will also track liver fibrosis markers, shifts in alcohol use, and body weight both at 24 and 48 weeks. This study is a key step in examining the safety and potential benefits of pemvidutide for ALD patients.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- June 26, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH).
AI Summary
Altimmune recently announced positive topline results from their IMPACT Phase 2b trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study enrolled 212 participants with confirmed MASH, and the trial met its primary endpoint by showing that pemvidutide led to significant MASH resolution without worsening fibrosis. Notably, 59.1% of patients receiving the 1.2 mg dose and 52.1% on the 1.8 mg dose achieved MASH resolution, compared to only 19.1% in the placebo group.
A supplemental AI-based analysis revealed statistically significant reductions in liver fibrosis, with 30.6% of patients on the 1.8 mg dose experiencing a 60% or greater reduction in fibrosis. Additionally, participants experienced up to 6.2% weight loss at 24 weeks, and the treatment was well-tolerated with very few discontinuations due to side effects.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- June 25, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. to present topline 24 week data from its IMPACT Phase 2b trial evaluating pemvidutide in the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH).
AI Summary
Altimmune, Inc. is set to present topline 24-week data from its IMPACT Phase 2b trial during an investor webcast on June 26, 2025, at 8:30 am ET. The trial is testing pemvidutide, a novel peptide-based therapeutic, for treating metabolic dysfunction-associated steatohepatitis (MASH). In this trial, 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3, both with and without diabetes, are being evaluated. Participants are receiving weekly subcutaneous doses of pemvidutide at doses of 1.2 mg or 1.8 mg, or a placebo, over 24 weeks with the primary goals of achieving MASH resolution or fibrosis improvement. The study also monitors secondary outcomes like weight loss and non-invasive tests. Patients will undergo a total of 48 weeks of treatment, and additional data is expected in the fourth quarter of 2025.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- June 13, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc announced an oral presentation and three poster presentations on pemvidutide at the American Diabetes Association's (ADA) 85th Scientific Sessions, to be held in Chicago, IL from June 20-23, 2025.
AI Summary
Altimmune, Inc. announced that it will present its latest research on pemvidutide at the American Diabetes Association's 85th Scientific Sessions in Chicago, IL, from June 20-23, 2025. The company will feature one oral presentation and three poster presentations during the conference. The oral session, scheduled for June 21, 2025, from 4:30 PM to 6:00 PM CDT, will discuss the effects of pemvidutide—a novel GLP-1/glucagon dual receptor agonist—on cardioinflammatory lipids in subjects with obesity or overweight. Additionally, two poster presentations on June 22, 2025, will cover cardiovascular safety and risk reduction, as well as reductions in visceral adipose tissue measured by MRI. A third poster will explore how pemvidutide enhances reverse cholesterol transport through an animal study. More details about these presentations are available on Altimmune’s website.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- May 19, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD).
AI Summary
Altimmune, Inc. has started its RECLAIM Phase 2 trial by enrolling the first subject to evaluate the safety and effectiveness of pemvidutide in patients with Alcohol Use Disorder (AUD). This new trial is a randomized, placebo-controlled study taking place at about 15 sites across the United States. It will involve roughly 100 subjects who will receive either 2.4 mg of pemvidutide or a placebo once a week for 24 weeks.
The primary goal of the trial is to measure changes in alcohol consumption by tracking the average number of heavy drinking days per week at the end of the study period. Additionally, the study will look at secondary outcomes such as the number of patients who reduce their drinking levels significantly and changes in a specific blood biomarker linked to alcohol intake.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- May 8, 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced the presentation of new analyses at the European Association for the Study of the Liver (EASL) Congress™ in Amsterdam, The Netherlands. The presentation focuses on the use of the MASH Resolution Index (MASHResInd) algorithm to predict MASH resolution on biopsy in patients treated with pemvidutide, Altimmune's 1:1 GLP-1/glucagon dual receptor agonist.
AI Summary
Altimmune, Inc. announced new analyses at the European Association for the Study of the Liver (EASL) Congress™ in Amsterdam. The focus of the presentation was the use of the MASH Resolution Index (MASHResInd) algorithm to predict MASH resolution on biopsy in patients treated with pemvidutide, the company's 1:1 GLP-1/glucagon dual receptor agonist.
The MASHResInd algorithm, developed by Dr. Rohit Loomba, combines non-invasive tests, such as MRI-PDFF, ALT, and AST levels, to assess improvements in liver histology. The analyses from a previous trial showed that pemvidutide treatment led to high rates of MASHResInd responses, indicating a strong likelihood of MASH resolution. These results support the potential of pemvidutide to achieve meaningful changes in liver disease and provide confidence as the IMPACT Phase 2b Trial progresses.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- September 30, 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide.
AI Summary
Altimmune, Inc. announced that patient enrollment is now complete for its IMPACT Phase 2b trial evaluating pemvidutide in approximately 190 participants with metabolic dysfunction-associated steatohepatitis (MASH). The trial, which is unique due to its biopsy-driven fibrosis endpoint assessment at 24 weeks, is expected to deliver top-line efficacy data in the second quarter of 2025. This development is a key step in evaluating pemvidutide’s dual benefits of direct liver effects and weight loss for patients with MASH.
In addition to completing enrollment in the IMPACT trial, the company provided an update on its regulatory initiatives. It confirmed an End-of-Phase 2 meeting with the FDA for its obesity program scheduled for early November 2024. Altimmune is also planning to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications starting in Q4 2024, aiming to broaden its potential impact in addressing metabolic diseases.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- September 30, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4 2024
AI Summary
Altimmune, Inc. announced plans to expand its research on pemvidutide by filing Investigational New Drug (IND) applications for up to three additional indications starting in the fourth quarter of 2024. This move is part of the company’s effort to explore new therapeutic areas within the metabolic disease space. Altimmune seeks to build on pemvidutide’s dual action on GLP-1 and glucagon receptors, which may help with weight loss, reduction in liver fat, and improved lipid profiles. The IND filings support the company’s strategy to evaluate the drug further in patient populations with unmet medical needs, potentially addressing conditions like obesity and other metabolic disorders. Details on these additional indications will be shared after alignment with the U.S. FDA, with preparations for the first trial already underway and an anticipated start in the first half of 2025.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- September 10, 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc today presented data from its Phase 2, MRI-based body composition sub-study of pemvidutide in subjects with overweight and obesity at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH)..
AI Summary
Altimmune, Inc. presented promising data on pemvidutide at the 60th Annual Meeting of the European Association for the Study of Diabetes in Madrid. The data came from a Phase 2, MRI-based body composition sub-study that focused on subjects with overweight and obesity. In this study, 67 subjects from the MOMENTUM trial were analyzed, with 50 receiving pemvidutide for 48 weeks. The findings revealed a lean loss ratio of 21.9% overall, indicating strong preservation of lean mass. Notably, subjects aged 60 and older experienced an even lower lean loss ratio of 19.9%, a key point since maintaining lean mass in older individuals can help reduce risks of falls, fractures, and other health issues. Additionally, the treatment resulted in a 25.6% reduction in visceral adipose tissue, which is associated with a reduced risk of cardiovascular disease. Pemvidutide is an investigational dual receptor agonist targeting both GLP-1 and glucagon pathways for obesity and MASH treatment.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- September 3, 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced that the data from its Phase 2, MRI-based body composition sub-study of pemvidutide in subjects with overweight and obesity will be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes in Madrid, Spain.
AI Summary
Altimmune, Inc. announced that new data from its Phase 2, MRI-based body composition sub-study of pemvidutide in overweight and obese subjects will be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes in Madrid, Spain. This study focuses on how pemvidutide preserves lean body mass during weight loss while targeting metabolic factors.
The investigational peptide acts as a dual receptor agonist by activating both GLP-1 and glucagon receptors. Data from the study, which examines body composition changes during weight loss, will be delivered by Dr. Sarah Browne, Vice President of Clinical Development, during an oral session on Tuesday, September 10, 2024, at 1:45 pm CEST. These innovative results fuel hope for improved treatments in managing obesity and related metabolic disorders.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- July 25, 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced the data from its 12-week clinical trial of pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, in metabolic dysfunction-associated steatotic liver disease (MASLD) has been published in the Journal of Hepatology.
AI Summary
Altimmune, Inc. has announced promising results from its 12-week clinical trial of pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The study, published in the Journal of Hepatology, showed that weekly subcutaneous doses of pemvidutide led to up to a 68.5% reduction in liver fat content, with more than half of the participants achieving complete normalization of liver fat levels.
The trial also reported significant improvements in body weight and non-invasive markers of liver inflammation. Nearly all subjects treated with pemvidutide experienced at least a 30% reduction in liver fat, a key indicator predicting resolution of MASH and improvement in fibrosis. Altimmune is encouraged by these data and looks forward to further results from its ongoing Phase 2b IMPACT trial next year.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced that Pemvidutide is currently being evaluated in the Phase 2b IMPACT trial in subjects with metabolic dysfunction-associated steatohepatitis (MASH), with data readout expected in Q1 2025
AI Summary
Altimmune, Inc. announced that its investigational drug pemvidutide is being tested in the ongoing Phase 2b IMPACT trial for patients with metabolic dysfunction-associated steatohepatitis (MASH). This novel dual receptor agonist works on both GLP-1 and glucagon receptors, aiming to improve liver health and reduce body weight.
Earlier studies showed that once-weekly doses of pemvidutide led to up to a 68.5% reduction in liver fat content, with 55.6% of subjects reaching normal liver fat levels. These results suggest that pemvidutide could become a strong treatment option for MASH. The ongoing Phase 2b IMPACT trial is expected to provide more data on the drug’s effectiveness, with findings anticipated in the first quarter of 2025.
Read Announcement- Drug:
- pemvidutide
- Announced Date:
- June 18, 2024
- Indication:
- for the treatment of obesity and MASH
Announcement
Altimmune, Inc. announced oral presentations on pemvidutide, an investigational GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH, at the American Diabetes Association's (ADA) 84th Scientific Sessions, to be held in Orlando, FL from June 21-24, 2024.
AI Summary
Altimmune, Inc. announced that it will present new data on pemvidutide at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida, from June 21-24, 2024. Pemvidutide is an investigational peptide that works as a dual GLP-1/glucagon receptor agonist and is being developed to treat obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The oral presentations will cover findings from recent trials, including investigations of its effects on cardioinflammatory lipids and a 48-week Phase 2 study in subjects with overweight or obesity. One presentation, led by Dr. Louis Aronne, will also appear in the official ADA Press Program. These sessions are expected to provide further insights into how pemvidutide mimics the benefits of diet and exercise, such as appetite suppression, increased energy expenditure, and improved liver fat metabolism.
Read Announcement
Pemvidutide (ALT-801) Obesity - FDA Regulatory Timeline and Events
Pemvidutide (ALT-801) Obesity is a drug developed by Altimmune for the following indication: Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pemvidutide (ALT-801) Obesity
- Announced Date:
- February 27, 2025
- Indication:
- Obesity
Announcement
Altimmune, Inc. provided a business update.
AI Summary
Altimmune, Inc. provided a business update highlighting significant progress on its lead candidate, pemvidutide. The company finished enrolling patients in its Phase 2b IMPACT trial for metabolic dysfunction-associated steatohepatitis (MASH), with top-line data expected in the second quarter of 2025. Altimmune’s enrollment success, described as one of the fastest in a biopsy-driven trial, underscores the strong interest from patients and providers due to pemvidutide’s ability to reduce liver fat and body weight.
Additionally, the company submitted Investigational New Drug applications for two new indications in the fourth quarter of 2024. Both INDs have received FDA clearance, setting the stage for Phase 2 efficacy studies to begin by mid-2025. Altimmune will further detail these developments during its upcoming virtual R&D Day on March 13, 2025, featuring presentations from company executives and industry experts.
Read Announcement- Drug:
- Pemvidutide (ALT-801) Obesity
- Announced Date:
- May 29, 2024
- Indication:
- Obesity
Announcement
Altimmune, Inc. announced that new data on the anti-inflammatory and anti-fibrotic properties of pemvidutide in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) will be presented at the EASL International Liver Congress™ 2024 in Milan, Italy.
AI Summary
Altimmune, Inc. announced that new data on the anti-inflammatory and anti-fibrotic effects of pemvidutide in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) will be presented at the upcoming EASL International Liver Congress™ 2024 in Milan, Italy. The presentations, scheduled for June 5, 2024, will highlight findings from several studies, including a quantitative systems pharmacology model, plasma lipidomic profiling, and a 24‐week clinical trial that assessed improvements in noninvasive tests of liver health. Pemvidutide is an investigational, peptide-based GLP-1/glucagon dual receptor agonist being developed for the treatment of obesity and related liver disease. By activating GLP-1 and glucagon receptors, pemvidutide aims to support weight loss and reduce liver fat, offering benefits that mimic the positive effects of diet and exercise while potentially lowering serum lipid levels.
Read Announcement
