Company Description
Altimmune, Inc. (Nasdaq: ALT) is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver, metabolic and cardiometabolic diseases. According to the company’s public disclosures, Altimmune’s work centers on serious liver conditions and related metabolic disorders, with its development efforts concentrated around a single lead investigational medicine, pemvidutide.
Altimmune is incorporated in Delaware and its common stock trades on The Nasdaq Global Market under the ticker symbol ALT, as noted in multiple SEC filings. The company is based in Gaithersburg, Maryland, where it conducts its corporate activities and oversees its clinical programs.
Core focus and lead product candidate
Altimmune describes itself as a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases. Across recent press releases and SEC reports, the company consistently identifies pemvidutide as its lead product candidate. Pemvidutide is characterized as a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity.
Company materials state that pemvidutide is in development for:
- Metabolic dysfunction-associated steatohepatitis (MASH)
- Alcohol use disorder (AUD)
- Alcohol-associated liver disease (ALD)
- Obesity (as referenced in an Altimmune press release about its pipeline focus)
Altimmune highlights that activation of glucagon receptors by pemvidutide is associated with direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while activation of GLP-1 receptors is associated with metabolic effects such as appetite suppression and weight loss. These mechanistic descriptions come directly from the company’s press releases on pemvidutide.
Clinical development programs
Altimmune reports that it is a late clinical-stage company, reflecting the status of its lead program in MASH and additional Phase 2 programs. Key disclosed clinical activities include:
- IMPACT Phase 2b trial in MASH: A randomized, placebo-controlled, double-blind study (NCT05989711) enrolling 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3, with and without diabetes. Participants received weekly subcutaneous pemvidutide (1.2 mg or 1.8 mg) or placebo for 48 weeks. Company announcements describe primary efficacy endpoints at 24 weeks focused on MASH resolution without worsening of fibrosis or fibrosis improvement without worsening of MASH, with secondary endpoints including non-invasive tests of fibrosis and weight loss.
- Phase 2 RECLAIM trial in AUD: A Phase 2 trial (RECLAIM, NCT06987513) evaluating pemvidutide in adults with alcohol use disorder, in subjects with obesity or who are overweight. Approximately 100 patients are randomized to receive pemvidutide or placebo once weekly for 24 weeks. Disclosed primary and secondary endpoints include changes in heavy drinking days and measures such as World Health Organization risk drinking level and phosphatidylethanol (PEth) levels.
- Phase 2 RESTORE trial in ALD: A 48-week Phase 2 study (RESTORE) evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with alcohol-associated liver disease, as described in Altimmune’s business updates.
In its communications, Altimmune emphasizes that these trials are designed to evaluate both liver-related outcomes and broader metabolic parameters such as weight loss and non-invasive markers of fibrosis and hepatic inflammation.
Regulatory designations and interactions
Altimmune has disclosed several key regulatory milestones for pemvidutide:
- The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, based on company press releases describing these designations as addressing areas of significant unmet medical need.
- The FDA has granted Breakthrough Therapy Designation for pemvidutide in MASH, as announced in a January 2026 press release. This designation was based on 24-week data from the IMPACT Phase 2b trial showing statistically significant MASH resolution without worsening of fibrosis, along with improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation.
- Altimmune reports that it completed an end-of-Phase 2 meeting with the FDA for its MASH program, resulting in alignment on parameters for a planned registrational Phase 3 trial of pemvidutide in MASH patients with moderate to advanced liver fibrosis.
Company statements also note plans to incorporate AI-based pathology tools, such as AIM-MASH AI Assist, into future Phase 3 studies, reflecting Altimmune’s interest in integrating AI-supported histologic assessment and non-invasive endpoints into its clinical development strategy.
Use of AI and advanced assessment methods
Altimmune has reported the use of AI-based digital pathology in analyzing liver biopsies from the IMPACT Phase 2b trial. In a press release on AI-based analysis, the company describes the use of the Liver Explore tool to quantify changes in early, advanced and total liver fibrosis. The company reports that pemvidutide treatment resulted in significant reductions in fibrosis areas compared with placebo, and that these findings were consistent with improvements in non-invasive tests of fibrosis.
Altimmune communications also reference the FDA qualification of AIM-MASH AI Assist, described as an AI pathology tool intended to help standardize histologic assessment and reduce time and resource requirements in MASH drug development. Altimmune indicates its intent to integrate such tools into its planned Phase 3 MASH trial design.
Capital markets and financing
Altimmune’s SEC filings provide information on its capital structure and financing activities. The company’s common stock has a par value of $0.0001 per share and is registered under Section 12(b) of the Securities Exchange Act of 1934, trading on The Nasdaq Global Market under the symbol ALT. In a November 2025 Form 8-K, Altimmune disclosed an Equity Distribution Agreement with a sales agent for an at-the-market offering program allowing the company to offer and sell shares of common stock up to a specified aggregate offering price, pursuant to an effective shelf registration statement on Form S-3.
Another Form 8-K describes an amendment to a Loan and Security Agreement with Hercules Capital, Inc., increasing the availability under a term loan facility and extending the interest-only period. These filings indicate that Altimmune uses a combination of equity and debt financing tools to support its operations and clinical development programs.
Corporate governance and stockholder matters
In its definitive proxy statement (DEF 14A) and related filings, Altimmune outlines its corporate governance structure, including a board of directors elected annually by stockholders, and standard agenda items for its annual meeting such as the election of directors, ratification of the independent registered public accounting firm, and an advisory vote on executive compensation. The company’s proxy materials also describe its practice of holding annual meetings virtually and providing stockholders with multiple options to vote, including via the Internet, telephone or proxy card.
Industry classification and sector
Based on the provided industry classification, Altimmune operates within Pharmaceutical Preparation Manufacturing in the broader Manufacturing sector. Its own public descriptions consistently identify it as a biopharmaceutical company with a focus on liver, metabolic and cardiometabolic diseases, and on the development of peptide-based drug candidates rather than approved commercial products.
ALT stock: what investors track
Investors following ALT stock, as reflected in Altimmune’s news releases and SEC reports, typically monitor:
- Progress and results from the IMPACT Phase 2b MASH trial and related analyses
- Advancement of the RECLAIM (AUD) and RESTORE (ALD) Phase 2 trials
- Regulatory interactions and designations for pemvidutide
- Financing activities, including at-the-market offerings and term loan arrangements
- Corporate updates such as executive leadership changes and board composition, as disclosed in Forms 8-K and proxy statements