Longeveron® Results of Phase 2b Clinical Trial Demonstrating Stem Cell Therapy Improved Condition of Patients with Age-Related Frailty Published in Cell Stem Cell
Rhea-AI Summary
Longeveron (NASDAQ: LGVN) reported Phase 2b results published in Cell Stem Cell showing intravenous laromestrocel improved physical condition in 148 ambulatory patients with age-related frailty versus placebo. 6-minute walk test (6MWT) increased by 63.4m at month 9 (95% CI: 17.1–109.6m; p=0.0077). Findings include dose-response signals and a potential TIE-2 biomarker for responsiveness.
Positive
- 6MWT +63.4m at month 9 (p=0.0077)
- Randomized Phase 2b trial with N=148 ambulatory frailty patients
- Dose-dependent functional improvements and PROMIS correlation
- Potential biomarker signal: decreased soluble TIE-2 with higher doses
Negative
- Month 6 result not statistically significant (6MWT +41.3m; p=0.0635)
- Phase 2b data are exploratory and do not imply regulatory approval
- Limited population: ambulatory individuals only, may limit generalizability
News Market Reaction – LGVN
On the day this news was published, LGVN declined 5.63%, reflecting a notable negative market reaction. Argus tracked a peak move of +25.6% during that session. Argus tracked a trough of -8.9% from its starting point during tracking. Our momentum scanner triggered 24 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $879K from the company's valuation, bringing the market cap to $15M at that time. Trading volume was exceptionally heavy at 33.5x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
LGVN was up 2.78% while momentum data flagged only EDSA, which moved -13.14% with no news. With just one peer in motion and in the opposite direction, trading appeared stock-specific rather than a coordinated biotech move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jun 24 | HLHS trial enrollment | Positive | +7.8% | Completed enrollment of pivotal Phase 2b HLHS trial with 40 pediatric patients. |
| Mar 11 | Alzheimer’s Phase 2a data | Positive | +5.4% | Nature Medicine publication of Phase 2a Alzheimer’s trial showing significant positive outcomes. |
| Oct 29 | CTAD24 data presentation | Positive | +0.5% | Presented Lomecel-B Phase 2a Alzheimer’s data linking MMP14 inhibition to improved outcomes. |
| Oct 14 | CTAD24 poster selection | Positive | +8.4% | Lomecel-B Alzheimer’s data selected for late-breaking poster at CTAD24 conference. |
| Jul 28 | AAIC trial results | Positive | +0.9% | AAIC presentation of Phase 2a Alzheimer’s data showing improved cognition and reduced brain volume loss. |
Clinical-trial news has generally coincided with positive next-day moves, especially when tied to Alzheimer’s or HLHS milestones.
Over the last year, Longeveron’s key catalysts have centered on laromestrocel clinical progress. Positive Alzheimer’s Phase 2a data and multiple conference presentations in 2024 all produced modest gains, while the June 24, 2025 completion of enrollment for the pivotal HLHS Phase 2b trial led to a stronger 7.83% move. Across these 5 clinical-trial headlines, average next-day reaction was about 4.6%, suggesting that well-received data publications and trial milestones have historically supported the share price.
Historical Comparison
Past clinical-trial headlines for LGVN moved the stock about 4.6% on average. Today’s Phase 2b frailty publication and its 2.78% move sit on the lower end of that range.
Clinical milestones have progressed from Alzheimer’s Phase 2a data readouts and conference posters in 2024 to HLHS Phase 2b enrollment completion in 2025, with the current Phase 2b frailty publication adding another indication to the laromestrocel clinical story.
Market Pulse Summary
The stock moved -5.6% in the session following this news. A negative reaction despite positive Phase 2b frailty data would contrast with prior clinical-trial news, which averaged about a 4.6% gain the next day. Such a decline could reflect concern about the company’s small $12.06M market cap base, past going-concern language, or questions around commercial path rather than the data alone. Historically, sentiment around clinical milestones has skewed supportive, so sharp downside would mark a departure.
Key Terms
mesenchymal stem cell medical
allogeneic medical
6-minute walk test medical
promis physical function medical
biomarker medical
angiopoietins medical
tie-2 medical
randomized, dose-finding clinical trial medical
AI-generated analysis. Not financial advice.
MIAMI, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, today announced that results of its Phase 2b clinical trial were published today in Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. The full publication is available on the Cell Stem Cell website here.
Laromestrocel (LOMECEL-B®) is a proprietary, scalable, allogeneic stem cell (MSC) investigational therapy that is currently being evaluated in multiple indications.
“We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging-related frailty,” said Joshua M. Hare, MD, FACC, FAHA, Chief Science Officer at Longeveron. “Those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron’s mission – advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly.”
The Phase 2b, randomized, dose-finding clinical trial evaluated whether laromestrocel, human bone marrow-derived allogeneic MSCs, improves physical functioning and patient self-reported outcomes in 148 ambulatory individuals with frailty (NCT03169231). Laromestorcel infusions resulted in:
- Clinically meaningful, dose-and time-dependent increases in the primary endpoint of the 6-minute walk test (6MWT) compared with placebo: 63.4m (
95% confidence interval [CI]: 17.1-109.6m; p=0.0077) at month 9 and 41.3m (95% CI: -2.4-84.9m; p=0.0635) at month 6 - Increased 6MWT distance correlates with PROMIS Physical Function score
- Increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE-2), the cognate receptor for the angiopoietins, identifying a potential biomarker for laromestrocel responsiveness
These findings identify a possible stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel 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. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important 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. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, although not all forward-looking statements contain these words, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, the future restoration of executive compensation levels; our intention and ability to repay certain compensation amounts to executives or rehire employees currently furloughed; the grant of certain equity awards; market and other conditions, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our investigational product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our investigational product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the investigational product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational product candidates; our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our investigational product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc
FAQ
What did Longeveron (LGVN) announce about the Phase 2b frailty trial on February 25, 2026?
How large was the 6-minute walk test improvement in LGVN's Phase 2b frailty study?
Does Longeveron (LGVN) report a biomarker linked to laromestrocel response in the 2026 study?
What are the limitations of LGVN's Phase 2b frailty trial results for investors?
How might the Phase 2b publication in Cell Stem Cell affect Longeveron (LGVN) clinical plans?
