Longeveron Inc. (LGVN) announced that the U.S. FDA has granted the company a Type C meeting scheduled for late March, ahead of the anticipated third-quarter data readout from ELPIS II, its pivotal Phase 2 clinical trial evaluating the investigational stem-cell therapy Laromestrocel (Lomecel-B) for Hypoplastic Left Heart Syndrome.
Hypoplastic Left Heart Syndrome (HLHS) is a rare and life-threatening congenital heart defect in which the left side of the heart is severely underdeveloped. Even with the current three-stage surgical reconstruction pathway, only about half of infants survive to adolescence, underscoring the urgent need for new therapeutic options.
Laromestrocel is an allogeneic, medicinal signaling cell therapy designed to improve cardiac function by promoting tissue repair and modulating inflammation. It has received Rare Pediatric Disease, Orphan Drug, and Fast Track designations from the FDA for HLHS.
Why a Type C Meeting - and Why Now?
Longeveron requested this Type C meeting because the company wants FDA feedback on key regulatory components of the ELPIS II program ahead of the pivotal data readout expected in Q3 2026.
The meeting will focus on clinical efficacy endpoints and the statistical analysis plan (SAP) to support a Biologics License Application (BLA).
ELPIS II topline results are expected in Q3 2026, and the company aims to ensure that the dataset- if positive- will be acceptable for a full traditional BLA submission.
Longeveron noted that the upcoming meeting builds on prior FDA interactions in which the agency provided guidance on the pivotal status of ELPIS II, as well as on trial design, endpoints, and CMC and potency assay considerations. The company stated that the March meeting represents the next step in preparing for potential registration activities should the Phase 2 results demonstrate a clinically meaningful benefit.
ELPIS II is a Phase 2b clinical trial evaluating Laromestrocel as a potential adjunct therapy for HLHS. The study enrolled 40 pediatric patients across twelve leading infant and children's treatment centers in the United States and is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institutes of Health.
According to Longeveron, the trial is designed to assess cardiac functional outcomes, survival without transplantation, and long-term ventricular performance. If successful, the results could support a full traditional BLA submission, positioning Larmomestrocel as a potential first-in-class regenerative therapy for this high-risk pediatric population.
The company expects to provide a regulatory update after receiving the official FDA meeting minutes.
LGVN has traded between $0.49 and $1.92 over the past year. The stock is currently trading at $0.60, up 3.27%.
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