Longeveron HLHS Trial Misses Primary Endpoint, Shows Fewer Cardiac Events
Longeveron reported that its Phase 2b ELPIS II trial of laromestrocel for hypoplastic left heart syndrome missed its primary endpoint but met a statistically significant secondary endpoint. Major adverse cardiac events totaled 8 in the standard-care group versus 1 in the treatment group. Longeveron plans to discuss the results and next steps with the FDA, with findings scheduled for presentation at the American Heart Association's 2026 Scientific Sessions.
Why it matters
The primary-endpoint miss complicates the regulatory path for laromestrocel, while the favorable secondary result gives Longeveron a basis for its planned FDA discussion. The company's next regulatory steps remain subject to that meeting.
Key facts
- 1The Phase 2b trial involved 40 infants followed for 12 months. rttnews.com
- 2The secondary endpoint recorded 8 major adverse cardiac events with standard care versus 1 with laromestrocel. tradingview.com
- 3The trial missed its primary endpoint, according to Longeveron. tradingview.com
- 4Longeveron plans to meet with the FDA to discuss next steps and present the findings at the American Heart Association's 2026 Scientific Sessions. tradingview.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.