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Longeveron Shares Halted After Heart Therapy Trial Misses Primary Endpoint

Longeveron Shares Halted After Heart Therapy Trial Misses Primary Endpoint

MT newswireMT newswire2026/09/16 22:07
06:07 PM EDT, 09/16/2026 (MT Newswires) -- Longeveron (LGVN) shares were halted Wednesday after the company reported that ELPIS II, its phase 2b trial of stem cell therapy laromestrocel in 40 infants with hypoplastic left heart syndrome, did not meet its primary endpoint of change in right ventricular ejection fraction at Month 12. The company said laromestrocel's safety profile remained consistent with prior trials, with no new safety signals identified. Exploratory analyses showed no deaths in the treated group over 12 months, versus one in the control group, and about 31% fewer adjudicated major adverse cardiovascular events, although the difference was not statistically significant. Longeveron said it will discuss the results with the FDA to determine potential next steps and has begun a process to review all options to maximize shareholder value, including engaging an investment bank as a strategic advisor.
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