Longeveron Completes Enrollment Of Phase 2b Clinical Trial Evaluating Investigational Cellular Therapy Laromestrocel As Potential Adjunct Treatment For Hypoplastic Left Heart Syndrome

Author: Benzinga Newsdesk | June 24, 2025 06:31am

• Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months
• Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive
• U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation
• Laromestrocel HLHS program addresses unmet medical needs with U.S. market potential of up to $1 billion

MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it has achieved full enrollment of the Phase 2b clinical trial (ELPIS II) evaluating its investigational cellular therapy laromestrocel as a potential adjunct treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease. Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months. Laromestrocel is a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications.

Posted In: LGVN