Laromestrocel Cuts Major Cardiac Events 8-to-1 in HLHS Trial Secondary Endpoint
LGVN sits 18% above its 52-week low of $1.31.
Summary
Longeveron's ELPIS II trial missed its primary RVEF endpoint, but the planned additional analysis found the pre-specified secondary MACE endpoint hit statistical significance: 8 major adverse cardiac events in the standard-of-care arm versus 1 in the laromestrocel arm (P=0.043). Total major cardiac events were 22 versus 3, a rate ratio of 0.16 (p<0.001), and there were no treatment-related serious adverse events through 12 months. This is the first piece of good clinical news since the September primary endpoint failure, which the company followed with an 8-K saying it was exploring all options; the CMO also resigned October 14. Management now says it will request an FDA meeting to discuss next steps for the HLHS program, though the FDA has already told the company RVEF alone would not support approval. The data will get a Late-Breaking Science podium presentation at the AHA Scientific Sessions in Chicago on November 8, 2026.
At the time of this announcement, LGVN was trading at $1.55 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.1M. The 52-week trading range was $1.31 to $12.30. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.