Longeveron Secures FDA Meeting to Prepare for ELPIS II Data
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4d ago
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Longeveron announced that the U.S. Food and Drug Administration has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout of ELPIS II, the pivotal Phase 2 clinical trial evaluating the Company's proprietary stem cell therapy, laromestrocel, as a potential treatment for Hypoplastic Left Heart Syndrome, a rare pediatric and orphan-designated disease. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints and statistical analysis plan to support a Biologics Licensing Application. The Company expects to provide a regulatory update after the receipt of the official meeting minutes. ELPIS II is a Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy for HLHS. The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children's treatment institutions across the country. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institutes of Health.
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Analyst Views on LGVN
Wall Street analysts forecast LGVN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for LGVN is 3.50 USD with a low forecast of 3.00 USD and a high forecast of 4.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.580
Low
3.00
Averages
3.50
High
4.00
Current: 0.580
Low
3.00
Averages
3.50
High
4.00
About LGVN
Longeveron Inc. is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B has multiple potential mechanisms of action, encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. The Company is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Lomecel-B development programs have received five distinct FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Longeveron Secures Japanese Patent for Stem Cell Therapy Assays
- Patent Grant: The Japan Patent Office has granted Longeveron a patent covering potency assay methods for assessing human mesenchymal stem cells derived from various tissues, securing patent rights in Japan until 2041, thereby enhancing the protection of its clinical programs.
- Clinical Trial Progress: Longeveron's proprietary mesenchymal stem cell therapy, laromestrocel, has shown positive initial results across five clinical trials in three indications, demonstrating its potential in treating rare and aging-related diseases, which further solidifies its market position.
- Global Patent Portfolio Expansion: This patent issuance brings Longeveron's global intellectual property portfolio to 33 patents, reflecting the company's innovative capabilities in cell therapy and enhancing its competitive edge, potentially attracting more investor interest.
- Future Development Plans: Longeveron is conducting a pivotal Phase 2b clinical trial for HLHS, with results expected in Q3 2026, which may lay the groundwork for a Biologics License Application (BLA) with the FDA, further advancing its product commercialization efforts.
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Longeveron Joins JPM Healthcare Week to Focus on Alzheimer's Disease
- Participation in Healthcare Summit: Longeveron will participate in the StartUp Health Alzheimer’s & Brain Health Moonshot during JPM Healthcare Week in January 2026, aiming to accelerate breakthroughs in Alzheimer’s and Parkinson’s diseases, showcasing its leadership in the biotechnology sector.
- Investor Meeting Arrangements: The company will host meetings with institutional investors and potential partners during the event, aiming to foster connections that could drive future funding and collaboration opportunities, thereby enhancing market confidence.
- Product Development Progress: Longeveron’s lead product, laromestrocel (LOMECEL-B®), is under development for multiple diseases including Alzheimer’s, having received five significant FDA designations, indicating its potential in clinical stages.
- Strategic Partnerships: By collaborating with the Alzheimer’s Drug Discovery Foundation and Gates Ventures, Longeveron further solidifies its position within the Health Moonshot initiative, demonstrating its commitment to addressing unmet medical needs.
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