Longeveron Gets US FDA Approval for Phase 2 Trial of Laromestrocel

MT Newswires Live

2025/07/08

Longeveron (LGCN) said Tuesday the US Food and Drug Administration has cleared its investigational new drug application for stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy.

The company said it plans to begin phase 2 clinical trials in H1 2026. There are currently no approved therapies for pediatric dilated cardiomyopathy, the company said.

Laromestrocel is a proprietary investigational cellular therapy derived from mesenchymal stem cells that may lead to anti-inflammatory, pro-vascular regenerative responses, the company said.

Shares of Longeveron were up 7% in Tuesday morning trading.

Price: 1.38, Change: +0.09, Percent Change: +6.98

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