Trial Profile

Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS) : A Phase IIb Clinical Trial

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 03 Apr 2026

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At a glance

17 Mar 2026 According to a Longeveron media release, ELPIS II may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacy, anticipated in 2027.
12 Mar 2026 According to a Longeveron media release, the company announced closing of private placement of up to 30 Million dollar. The net proceeds from the initial tranche of the financing are expected to fund the Company's current operating plans into the fourth quarter of 2026, past the anticipated pivotal Phase 2b ELPIS II clinical trial 3Q26 topline data readout.
05 Feb 2026 According to a Longeveron media release, Top-line trial results are anticipated in the third quarter of 2026.

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