Welcome to our dedicated page for Longeveron news (Ticker: LGVNR), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.
Longeveron Inc. (LGVNR) generates news as a clinical stage biotechnology company developing regenerative medicines based on its lead mesenchymal stem cell therapy, laromestrocel (Lomecel-B). Company announcements frequently focus on progress in clinical trials, new scientific data, intellectual property developments, and participation in major medical and industry forums.
Recent news highlights include updates on the pivotal Phase 2b ELPIS II trial evaluating laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome (HLHS), a rare pediatric congenital heart defect. Longeveron also reports on its Alzheimer’s disease program, including Phase 2 data from the CLEAR MIND trial showing MRI biomarker evidence of reduced neuroinflammation and associations with preserved brain volume and clinical outcomes in mild Alzheimer’s disease.
Investors and observers can also see coverage of patents granted in the United States and Canada for methods of using Longeveron’s proprietary mesenchymal stem cells to treat aging-related frailty with inflammaging, non-ischemic dilated cardiomyopathy, and female sexual dysfunction. Additional news items describe FDA regulatory milestones, such as designations for laromestrocel in HLHS and Alzheimer’s disease, and acceptance of an IND for Pediatric Dilated Cardiomyopathy.
This page aggregates company press releases and third-party coverage related to Longeveron’s clinical programs, scientific presentations at conferences like CTAD and CVCT, and corporate updates. Users interested in LGVNR stock can review these updates to understand how Longeveron’s stem cell therapy platform is being evaluated across rare pediatric and aging-related conditions.
Longeveron (NASDAQ: LGVN) applauds Congress passing the Mikaela Naylon Give Kids a Chance Act, which reauthorizes the Rare Pediatric Disease Priority Review Voucher (PPRV) Program and extends voucher eligibility for medicines approved by the FDA before September 30, 2029.
The company noted FDA Rare Pediatric Disease, Orphan Drug and Fast Track designations for its laromestrocel program in Hypoplastic Left Heart Syndrome (HLHS). The Phase 2b ELPIS II trial enrolled 40 pediatric patients at 12 centers, with top-line results anticipated in Q3 2026. Since 2024, PRVs have traded for $150–200 million each.
Longeveron (NASDAQ: LGVN) announced that the Japan Patent Office granted Japan Patent No. 2022-563984 for potency assay methods to assess human mesenchymal stem cells (MSCs), with protection through April 20, 2041 assuming annuity payments.
The patent expands Longeveron's international IP to 33 issued patents and supports development of laromestrocel (Lomecel-B). A pivotal Phase 2b trial in Hypoplastic Left Heart Syndrome (HLHS) is ongoing, with results expected in Q3 2026, which may enable a U.S. BLA submission depending on outcomes.
Longeveron (NASDAQ: LGVN) announced the U.S. FDA has granted a Type C meeting at the end of March 2026 to align on clinical efficacy endpoints and the statistical analysis plan to support a potential BLA for laromestrocel (LOMECEL-B) in Hypoplastic Left Heart Syndrome (HLHS).
ELPIS II topline results are anticipated in Q3 2026. ELPIS II is a Phase 2b trial that enrolled 40 pediatric patients at 12 centers, conducted in collaboration with NHLBI through NIH grants. Laromestrocel holds Rare Pediatric Disease, Orphan Drug, and Fast Track designations.
Longeveron (NASDAQ: LGVN) was selected as a StartUp Health Alzheimer’s & Brain Health Moonshot company and will participate in StartUp Health Apollo House during JPM Healthcare Week in January 2026. Apollo House is a founders-and-funders networking summit focused on Health Moonshots for Alzheimer’s, Parkinson’s and related conditions, supported by champions including the Alzheimer’s Drug Discovery Foundation and Gates Ventures.
Longeveron said it will host meetings with institutional investors and potential partners during the week; investors may request meetings by contacting info@longeveron.com.
Longeveron (NASDAQ: LGVN) announced that the U.S. Patent and Trademark Office granted U.S. Patent No. 12,496,316 on Dec. 17, 2025 for methods of administering isolated allogeneic mesenchymal stem cells (MSCs) to treat female sexual dysfunction and improve sexual quality of life.
The patent provides U.S. rights through 2038 with potential patent term or regulatory exclusivity extensions. The company noted female sexual dysfunction affects up to 46% of women and said the patent expands its aging-focused intellectual property portfolio. Longeveron anticipates pursuing licensing or partnering opportunities for development and commercialization of the therapy.
Longeveron (NASDAQ: LGVN) announced that its Chief Science Officer Dr. Joshua Hare and Chief Medical Officer Dr. Nataliya Agafonova will speak at the Global CardioVascular Clinical Trialists (CVCT) Forum in Washington, D.C., December 8-10, 2025.
The executives will join multiple panel discussions on cell therapy for heart failure, including delivery routes, cell types (mesenchymal stem cell therapy for dilated cardiomyopathy referencing POSEIDON and PATH AHEAD), and multi‑stakeholder debate on streamlining cell therapy innovation while maintaining evidence standards.
Longeveron (NASDAQ: LGVN) announced that the Canadian Intellectual Property Office granted Canadian Patent No. 3043594 covering methods to administer its proprietary mesenchymal stem cell therapy laromestrocel (LOMECEL-B) for treatment of aging-related frailty with inflammaging and for non-ischemic dilated cardiomyopathy (NIDCM).
The patent provides Longeveron with rights in Canada through 2037. The company cites prior Phase 1 and 2 studies that delivered positive initial results in aging-related frailty, including designed improvements in the six-minute walk test and physical functioning. The release emphasizes inflammaging links to frailty and notes MSCs have shown favorable changes in immunologic markers in vivo.
Longeveron (NASDAQ: LGVN) presented Phase 2 CLEAR MIND MRI biomarker data at CTAD 2025 showing that laromestrocel treatment was associated with reduced MRI-measured neuroinflammation (free water) versus placebo across multiple brain regions, most notably the hippocampus and temporal lobe.
Key trial signals include hippocampal free water reductions with dose response (Group 4: p=0.004, N=8; Group 3: p=0.037, N=8), additional regional p-values at week 39, correlated hippocampal volume preservation, clinical benefit, and prior RMAT and fast-track designations from FDA.
Longeveron (NASDAQ: LGVN) announced its submission titled “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” was selected for a poster at the 18th Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025), held Dec 1–4, 2025 in San Diego.
The poster appears in Poster Session 1 (Section 11: New Therapies and Clinical Trials) with scheduled viewing from Dec 1, 3:00 p.m. PT to Dec 2, 5:30 p.m. PT. The announcement summarizes laromestrocel (Lomecel-B) as a mesenchymal stem cell product proposed to have immunomodulatory and regenerative mechanisms relevant to Alzheimer’s research.
Longeveron (NASDAQ: LGVN) announced the U.S. Patent and Trademark Office granted U.S. Patent No. 12,465,620 for a method of treating aging-related frailty with inflammaging using human mesenchymal stem cells. The patent provides U.S. rights through 2038, with potential for patent-term or regulatory exclusivity extensions.
The company’s lead MSC therapy, laromestrocel, has delivered positive initial results across two clinical trials and prior Phase 1 and 2 studies were designed to show improvements in the six-minute walk test and physical functioning in aging-related frailty patients. Aging-related frailty is described as a multisystem syndrome linked to inflammaging.
