Welcome to our dedicated page for Altimmune news (Ticker: ALT), a resource for investors and traders seeking the latest updates and insights on Altimmune stock.
Altimmune Inc (ALT) is a clinical-stage biopharmaceutical company developing pemvidutide for obesity and metabolic dysfunction-associated steatohepatitis (MASH). The company's news flow centers on clinical trial updates, regulatory milestones, and corporate developments as pemvidutide advances through Phase 2 studies targeting the large and rapidly evolving metabolic disease market.
Investors following Altimmune can expect news related to clinical trial enrollments, topline data releases, and detailed study results from the company's pemvidutide development programs. The company announces material events including study initiations, enrollment completions, and data presentations at medical conferences. Clinical trial results represent the most market-moving news category for Altimmune, as efficacy and safety outcomes directly impact the development pathway and commercial potential for pemvidutide.
Regulatory updates form another significant news category, including FDA interactions, designation grants, and guidance on development pathways. The company also announces corporate developments such as executive appointments, financing activities, and strategic partnership discussions. Altimmune participates in investor conferences where management presents corporate updates and responds to analyst questions about clinical progress and development strategy.
Track Altimmune's clinical milestones, regulatory updates, and corporate developments with real-time news coverage and AI-powered analysis. Bookmark this page for comprehensive coverage of pemvidutide's clinical advancement and Altimmune's strategic developments in the competitive metabolic disease therapeutic landscape.
Altimmune (NASDAQ: ALT) announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for pemvidutide to treat metabolic dysfunction-associated steatohepatitis (MASH) on January 5, 2026. The designation was based on 24-week IMPACT Phase 2b data showing statistically significant MASH resolution without worsening fibrosis and early improvements in liver fat and non-invasive fibrosis/inflammation tests.
Altimmune reported 48-week topline data in December 2025 showing further statistically significant improvements in ELF and LSM, continued weight loss at the 1.8 mg dose, and a favorable tolerability profile. The company and FDA aligned on registrational Phase 3 parameters and plan a 52-week, biopsy-endpoint Phase 3 using multiple doses and AIM-MASH AI Assist; European scientific advice will also be sought.
Altimmune (Nasdaq: ALT) reported positive 48-week topline results from the IMPACT Phase 2b trial of pemvidutide in MASH patients on Dec 19, 2025. Both 1.2 mg and 1.8 mg doses produced statistically significant improvements in noninvasive fibrosis markers versus placebo, including ELF (‑0.49 and ‑0.58 vs +0.16; p<0.0001) and LSM (‑3.04 and ‑3.97 vs ‑0.03; p<0.05/0.001).
Additional 48-week highlights: liver fat down 45.2% and 54.7% (vs 8.2% placebo), ALT reductions ~‑38 IU/L (vs ‑10.3), weight loss 4.5% and 7.5% (vs 0.2%), low discontinuations, and FDA End‑of‑Phase 2 alignment to advance to a registrational Phase 3 planned for 2026.
Altimmune (Nasdaq: ALT) announced a CEO succession: Jerry Durso will become President and Chief Executive Officer effective January 1, 2026, while retaining his role as Chairman. Vipin Garg, Ph.D. will step down as CEO and serve as an advisor through June 30, 2026.
The company highlighted progress of its lead candidate, pemvidutide (dual glucagon/GLP-1 agonist), described as Phase 3 ready for MASH. Altimmune expects to hold an End-of-Phase 2 meeting with the FDA later this quarter and to report 48-week IMPACT Phase 2b data before year-end, including NIT, weight loss, and safety data.
Altimmune (NASDAQ: ALT) announced that its management team will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference.
The session is scheduled for Wednesday, December 3, 2025 at 2:30 p.m. ET and will be available via webcast. Investors can access the webcast through the Events section of Altimmune's website.
Altimmune (NASDAQ: ALT) announced publication in The Lancet of 24-week IMPACT Phase 2b results for pemvidutide in MASH and a late-breaking oral presentation at AASLD The Liver Meeting® 2025 on Nov 11, 2025.
Key 24-week findings: MASH resolution occurred in 58% (1.2 mg) and 52% (1.8 mg) versus 20% for placebo; liver fat normalization reached 31% and 44% versus 4% for placebo; mean weight reductions were −4.8% and −5.8% versus −0.5% for placebo. Multiple non-invasive tests (MRI-PDFF, FibroScan, cT1, ELF, PRO-C3, FAST) showed consistent improvements and liver stiffness fell by −3.7 kPa and −2.2 kPa for active doses. Safety/tolerability were described as favorable with low discontinuation rates. Altimmune said longer-term NIT and weight-loss readouts will be provided in Q4 2025.
Altimmune (Nasdaq: ALT) reported AI-based digital pathology analysis from the IMPACT Phase 2b pemvidutide trial in MASH showing significant fibrosis reductions vs placebo at 24 weeks.
Key results: 31% of patients on pemvidutide 1.8 mg achieved ≥60% total fibrosis area reduction (n=85) vs 8% placebo (n=86; p=0.0003); early fibrosis ≥60% reduction: 34% (1.8 mg) vs 9% placebo (p<0.0001); advanced fibrosis ≥60% reduction: 27% (1.8 mg) vs 11% placebo (p=0.0063). Non-invasive tests including PRO-C3:CTX-III ratio and PRO-C6 also improved.
Altimmune (Nasdaq: ALT) reported Q3 2025 corporate and financial updates on November 6, 2025. Key points: $210.8M cash, cash equivalents and short-term investments as of September 30, 2025 (about +60% vs. Dec 31, 2024); net loss of $19.0M (−$0.21 per share) for Q3 2025; R&D expense of $15.0M in Q3 2025. Important clinical milestones: an End-of-Phase 2 meeting with FDA scheduled Q4 2025 for pemvidutide MASH and 48-week IMPACT data expected before year-end 2025. Corporate: amended Hercules facility to $125M with an additional $20M draw, and three senior hires (CMO, CCO, CLO).
Altimmune (Nasdaq: ALT) said company management will attend two investor conferences in November 2025: a Stifel 2025 Healthcare Conference fireside chat on November 12, 2025 at 10:00 a.m. ET, and a Jefferies Global Healthcare Conference fireside chat on November 20, 2025 at 9:30 a.m. GMT. Management will be available for one-on-one meetings. Both sessions will be webcast and accessible via the Events section of the company's website.
Altimmune (Nasdaq: ALT) announced early completion of enrollment in RECLAIM, a Phase 2 trial of pemvidutide in adults with alcohol use disorder (AUD). Approximately 100 patients were randomized 1:1 to 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint is change in average number of heavy drinking days per week; key secondary endpoints include a 2-level WHO risk drinking reduction and change in PEth biomarker. Enrollment finished several months ahead of schedule and topline results are expected in 2026. Altimmune is also enrolling the RESTORE Phase 2 ALD trial and expects 48-week IMPACT results for MASH later this quarter.
Altimmune (Nasdaq: ALT) will report its third quarter 2025 financial results on Thursday, November 6, 2025. Management will host a conference call and webcast at 8:30 a.m. ET the same day to discuss results and provide a business update.
The live webcast will be available on Altimmune’s Investor Relations website and requires registration to receive dial-in numbers and a unique PIN. A replay of the call will be posted on the Investor Relations site and remain available for up to three months.
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