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Altimmune, Inc. develops pemvidutide, a late clinical-stage dual-action therapy targeting glucagon and GLP-1 receptors for serious liver diseases. Company news centers on pemvidutide development in metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), including clinical trial updates and FDA designations such as Fast Track and Breakthrough Therapy Designation where granted.
Altimmune updates also cover financial results, business updates, investor conference participation and capital actions used to fund development activity. Recurring financing news includes public offerings, registered direct offerings, common stock, pre-funded warrants and common stock warrants.
Altimmune (Nasdaq: ALT) reported second quarter 2026 results and a business update, highlighting advancement of its lead candidate pemvidutide in serious liver diseases. The company ended June 30, 2026 with $519 million in cash, cash equivalents and investments, supported by a completed $225 million public offering in April.
Altimmune initiated the global PERFORMA Phase 3 MASH trial, after pemvidutide received FDA Breakthrough Therapy and Fast Track designations for MASH. In AUD, the RECLAIM Phase 2 trial met its primary endpoint with a statistically significant reduction in heavy drinking days and achieved key FDA‑recognized secondary endpoints, with a generally favorable safety profile. In ALD, the company fully enrolled the RESTORE Phase 2 trial and amended the protocol to more fully assess liver benefits, with topline data expected in the second half of 2027.
For Q2 2026, Altimmune recorded R&D expenses of $18.7 million, G&A expenses of $7.6 million, and a net loss of $22.8 million, or $0.12 per share, compared with a $22.1 million net loss, or $0.27 per share, in Q2 2025.
Altimmune (Nasdaq: ALT) will report its second quarter 2026 financial results on Wednesday, August 12, 2026. Management will host a conference call and webcast at 8:30 a.m. ET to review results and provide a business update, with live access and a replay available via the company’s Investor Relations website.
Altimmune (Nasdaq: ALT) has begun enrolling patients in PERFORMA, a global, randomized, double-blind, placebo-controlled Phase 3 trial of investigational drug pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis.
PERFORMA is Altimmune’s registrational study in MASH, designed to evaluate fibrosis improvement, MASH resolution and clinical outcomes, with a 52-week data readout anticipated in 2029. The trial follows the IMPACT Phase 2b study, where pemvidutide showed statistically significant MASH resolution, improvements in non-invasive measures of fibrosis and liver health, meaningful weight loss, and a generally favorable tolerability profile. Pemvidutide, a balanced glucagon/GLP-1 dual receptor agonist, is also in development for alcohol use disorder and alcohol-associated liver disease. According to Altimmune, the study design incorporates feedback from the U.S. FDA and European regulators, and pemvidutide has received FDA Fast Track and Breakthrough Therapy designations for MASH.
Altimmune (Nasdaq: ALT) reported positive topline data from RECLAIM, a Phase 2 trial of pemvidutide 2.4 mg in patients with moderate to severe alcohol use disorder. The study met its primary endpoint, showing a least-squares mean reduction in heavy drinking days of 4.20 per week versus 2.75 with placebo, for a treatment difference of -1.45 (p=0.0014).
Key secondary endpoints also favored pemvidutide, including a two-level reduction in WHO Risk Drinking Levels in 64.4% of patients versus 34.8% on placebo (p=0.0049), zero heavy drinking days in Weeks 21–24 in 42.2% versus 17.4% (p=0.0066), increased abstinent days, and a large reduction in PEth levels. Pemvidutide produced a placebo-adjusted 9.1% body weight reduction at Week 24 (p<0.0001). Gastrointestinal adverse events were more frequent, but overall tolerability was described as generally favorable, with similar overall discontinuation rates to placebo. Altimmune plans to request an End-of-Phase 2 meeting with the FDA to discuss next steps in AUD.
Altimmune (Nasdaq: ALT) reported new 48‑week IMPACT Phase 2b data showing that pemvidutide significantly improved multiple metabolic risk factors in patients with MASH. The 1.8 mg dose reduced triglycerides by 23.7%, total cholesterol by 15.4%, weight by 7.5%, BMI by 3.0 kg/m2, waist circumference by 5.3 cm, and blood pressure.
Safety was maintained at 48 weeks, with about 1% discontinuation due to adverse events and mostly mild to moderate gastrointestinal events. Previously, 27.8% (1.2 mg) and 32.4% (1.8 mg) of patients achieved combined ELF and LSM improvements versus 3.2% on placebo.
Altimmune (Nasdaq: ALT) announced participation in two upcoming healthcare investor conferences in June 2026, featuring management fireside chats.
Events include the Jefferies Global Healthcare Conference in New York on June 4 and the Goldman Sachs Global Healthcare Conference in Miami Beach on June 10, with webcasts on Altimmune's website.
Altimmune (Nasdaq: ALT) reported new IMPACT Phase 2b data on pemvidutide in MASH at EASL 2026, showing concurrent improvements across multiple non-invasive tests of disease activity and fibrosis at 24 weeks. AI-based qFibrosis digital pathology also showed significant fibrosis regression, and Altimmune plans to begin the PERFORMA Phase 3 MASH trial in the second half of the year.
At 24 weeks, 37.8% on pemvidutide 1.2 mg and 22.7% on 1.8 mg achieved >0.5 ELF plus >30% LSM reductions versus 8.3% on placebo, while 68.6% and 54.5% on pemvidutide 1.2 mg and 1.8 mg, respectively, achieved ≥1-stage qFibrosis regression versus 29.6% on placebo.
Altimmune (Nasdaq: ALT) reported first quarter 2026 results and a business update. Cash, cash equivalents and short-term investments were $332 million on March 31, 2026 and $535 million on April 30, 2026, reflecting recent equity financings.
Pemvidutide received FDA Breakthrough Therapy Designation for MASH, with the global PERFORMA Phase 3 trial expected to start in the second half of 2026. Topline RECLAIM Phase 2 AUD data are expected in the third quarter of 2026, and RESTORE Phase 2 ALD enrollment is expected to complete in the same period.
First quarter 2026 R&D expenses were $16.2 million, G&A were $8.1 million, interest income was $2.9 million, and net loss was $22.6 million, or $0.18 per share.
Altimmune (Nasdaq: ALT) will present new pemvidutide data from the Phase 2b IMPACT trial in metabolic dysfunction-associated steatohepatitis (MASH) at the EASL Congress 2026 in Barcelona, May 27-30.
Presentations include 48-week efficacy and safety results, 24-week fibrosis regression by digital pathology, non-invasive test responses, and cardiovascular risk factor data. The 48-week abstract was selected for Best of EASL 2026.
Altimmune (Nasdaq: ALT) will report first quarter 2026 financial results on Wednesday, May 13, 2026 and will host a conference call at 8:30 a.m. ET the same day. The call will be webcast live on the company's Investor Relations website and a replay will be available for up to three months.
Altimmune is a late clinical-stage biopharmaceutical company developing pemvidutide for serious liver diseases; management will provide a business update during the call.