The broad metabolic data (lipid, weight, BP improvements) differentiates pemvidutide from pure GLP-1 agonists and supports a potential best-in-class profile for MASH. Key catalysts ahead: PERFORMA Phase 3 initiation (H2 2026), RECLAIM AUD topline (Q3 2026), and RESTORE ALD enrollment completion (Q3 2026). Monitor for partnership interest given the balanced glucagon/GLP-1 mechanism.
Price Chart
Executive Summary
Altimmune presented new 48-week data from the IMPACT Phase 2b trial of pemvidutide in MASH at the EASL Congress 2026. The data showed significant reductions in triglycerides (-23.7%), total cholesterol (-15.4%), weight (-7.5%), and blood pressure, alongside previously reported improvements in liver fibrosis biomarkers. The company plans to initiate the PERFORMA Phase 3 trial in the second half of 2026.
Key Facts
- Pemvidutide 1.8 mg reduced triglycerides by -23.7% and total cholesterol by -15.4% in MASH patients with elevated baseline lipids.
- Weight loss of 7.5% at 48 weeks with no plateauing; BMI reduction of -3.0 kg/m2; waist circumference reduction of -5.3 cm.
- Systolic blood pressure improved by -4.0 mmHg and diastolic by -2.2 mmHg.
- Previously reported fibrosis endpoints: 32.4% of pemvidutide 1.8 mg patients achieved ≥0.5 reduction in ELF and ≥30% reduction in LSM vs 3.2% for placebo (p<0.0001).
- Discontinuation rate due to AEs was ~1%; safety profile maintained at 48 weeks.
- FDA granted Fast Track and Breakthrough Therapy Designation for pemvidutide in MASH.
- PERFORMA Phase 3 trial expected to initiate in second half of 2026.
- RECLAIM Phase 2 trial in AUD topline data expected Q3 2026; RESTORE trial in ALD enrollment completion expected Q3 2026.
Financial Impact
No financial data provided; clinical-stage company with no approved products or revenue. Market cap ~$580M. Positive Phase 2b data supports Phase 3 initiation and potential regulatory path.
Risk Factors
- Phase 3 trial may fail to replicate Phase 2b efficacy or safety results.
- Competitive landscape includes Madrigal's Rezdiffra (approved) and other GLP-1/glucagon candidates from Novo Nordisk, Eli Lilly, and others.
- Company has no approved products and will require additional capital to fund Phase 3 and ongoing trials.
- Cardiovascular outcomes data not yet available; MASH patients face high CV mortality risk.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303064 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 29, 2026 27d ago | 8-K | $2.97 $2.67 | ▼ −10.10% | ▼ −12.05% | $2.09 (−29.63%) |
Aug 12, 2026 10w ago | 8-K | $2.93 $3.12 | ▲ +6.48% | ▲ +6.93% | $2.09 (−28.67%) |
Aug 12, 2026 10w ago | Press Release | $2.93 $3.12 | ▲ +6.48% | ▲ +6.93% | $2.09 (−28.67%) |
Aug 6, 2026 11w ago | Institutional Cluster | $3.01 $2.88 | ▼ −4.32% | ▼ −5.53% | $2.09 (−30.56%) |
Aug 5, 2026 11w ago | Press Release | $3.03 $2.93 | ▼ −3.30% | ▼ −3.65% | $2.09 (−31.02%) |
Aug 3, 2026 12w ago | Press Release | $3.00 $3.05 | ▲ +1.67% | ▼ −0.36% | $2.09 (−30.33%) |
Jul 28, 2026 12w ago | 8-K | $2.99 $3.00 | ▲ +0.33% | ▼ −1.93% | $2.09 (−30.10%) |
May 28, 2026 21w ago | Press Release | $3.07 $2.87 | ▼ −6.51% | ▼ −6.47% | $2.09 (−31.92%) |
May 27, 2026 21w ago | Press Release | $2.98 $2.90 | ▼ −2.68% | ▼ −3.89% | $2.09 (−29.87%) |
May 13, 2026 23w ago | 8-K | $3.02 $2.74 | ▼ −9.27% | ▼ −8.11% | $2.09 (−30.79%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers