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Longeveron Gains FDA Approval for Laromestrocel Trial

Story Highlights
  • Longeveron Inc. received FDA approval for a Phase 2 trial of laromestrocel for pediatric DCM.
  • The trial could revolutionize treatment for pediatric DCM, addressing a critical unmet need.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Longeveron Gains FDA Approval for Laromestrocel Trial

Elevate Your Investing Strategy:

An announcement from Longeveron ( (LGVN) ) is now available.

On July 8, 2025, Longeveron Inc. announced that the U.S. FDA has approved their Investigational New Drug application for laromestrocel, allowing the company to initiate a Phase 2 pivotal registration clinical trial for treating pediatric dilated cardiomyopathy (DCM). This approval marks a significant milestone in pediatric cardiovascular treatment, as current options are limited and often result in heart transplants or death for nearly 40% of affected children. The trial is expected to begin in the first half of 2026, and laromestrocel’s potential to repair damaged heart tissue could be groundbreaking for pediatric cardiovascular diseases.

The most recent analyst rating on (LGVN) stock is a Buy with a $6.00 price target. To see the full list of analyst forecasts on Longeveron stock, see the LGVN Stock Forecast page.

Spark’s Take on LGVN Stock

According to Spark, TipRanks’ AI Analyst, LGVN is a Neutral.

Longeveron faces considerable financial performance challenges, with significant losses and cash flow issues being the primary concerns. The technical analysis suggests some positive momentum, but the stock appears overbought. Valuation metrics are poor due to non-profitability and lack of dividends. However, the recent corporate event shows a proactive approach in aligning management incentives with shareholder interests, providing a slight positive outlook.

To see Spark’s full report on LGVN stock, click here.

More about Longeveron

Longeveron Inc. is a clinical stage biotechnology company specializing in regenerative medicine to address unmet medical needs. The company’s lead investigational product, laromestrocel, is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors. Longeveron is focused on developing treatments for conditions such as hypoplastic left heart syndrome, Alzheimer’s disease, and aging-related frailty, with laromestrocel having multiple potential mechanisms of action including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects.

Average Trading Volume: 295,570

Technical Sentiment Signal: Hold

Current Market Cap: $19.36M

Find detailed analytics on LGVN stock on TipRanks’ Stock Analysis page.

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