Longeveron (LGVN) Completes Enrollment of Pivotal Phase 2b Trial of Laromestrocel
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Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)
June 24, 2025 6:30 AM EDTTop-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS program addresses unmet medical needs with U.S. market potential of up to $1 billion
MIAMI, June 24, 2025 (GLOBE NEWSWIRE) --... More
