Short answer
Altimmune, Inc. (ALT) filed an 8-K current report with the SEC on July 28, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Positive topline RECLAIM Phase 2 results for pemvidutide 2.4 mg in moderate-to-severe alcohol use disorder.
Altimmune, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Positive topline RECLAIM Phase 2 results for pemvidutide 2.4 mg in moderate-to-severe alcohol use disorder
- Pemvidutide’s dual glucagon/GLP-1 mechanism expands potential beyond metabolic indications
- Clinical success could support further development in AUD and broaden Altimmune’s pipeline value
Item 8.01 · Other Events
- RECLAIM Phase 2 met its primary endpoint with highly significant reduction in heavy drinking days versus placebo
- Positive secondary outcomes included FDA registrational endpoints: two-level WHO risk reduction and zero heavy drinking days
- Reduced phosphatidyl ethanol levels supported pemvidutide’s effect on alcohol consumption
- Generally favorable safety and tolerability profile reduced near-term clinical risk
- Planned FDA End-of-Phase 2 meeting marks next regulatory step toward potential registrational development
Item EX-99.1 · Exhibit EX-99.1
- RECLAIM Phase 2 met its primary endpoint: HDD/week improved by 1.45 days versus placebo at Week 24, p=0.0014
- FDA-recognized registrational endpoints succeeded: two-level WHO-RDL reduction 64.4% vs 34.8%, zero HDD 42.2% vs 17.4%
- Objective PEth biomarker favored pemvidutide by 175.3 LS-mean units versus placebo, p<0.0001
- Gastrointestinal tolerability remains a development risk: nausea 44%, vomiting 18%, and drug-related discontinuations 10%
- Next regulatory catalyst: planned FDA End-of-Phase 2 meeting for AUD development path; larger-trial and financing risks remain ahead
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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