MIAMI, August 13, 2025 — Leads & Copy — Longeveron Inc. reported full enrollment in its pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication. Top-line trial results are anticipated in the third quarter of 2026, following the final 12-month follow-up.
The company anticipates submitting a Biological License Application (BLA) for laromestrocel in late 2026 for full traditional approval for HLHS, contingent on positive ELPIS II results. Additionally, the FDA has approved an IND application for laromestrocel as a potential treatment for Pediatric Dilated Cardiomyopathy, expanding Longeveron’s stem cell therapy pipeline.
Longeveron will host a conference call and webcast today at 4:30 p.m. ET.
Wa’el Hashad, Chief Executive Officer of Longeveron, noted that laromestrocel has demonstrated positive initial outcomes in five clinical trials across three indications.
Derek Cole, Investor Relations Advisory Solutions, derek.cole@iradvisory.com
Source: Longeveron Inc.
