Longeveron to report Phase 2b HLHS results in August after positive safety review

Longeveron (NASDAQ:LGVN) confirmed that the independent Data Monitoring Committee (DMC) has completed its final planned review of the Phase 2b ELPIS II trial.

The committee found no new safety concerns and recommended that the study continue as designed.

With the trial now fully enrolled, the company remains on track to release top-line results in August 2026.

The ELPIS II trial is evaluating the safety and efficacy of laromestrocel (Lomecel-B), an allogeneic bone marrow-derived medicinal signaling cell (MSC) therapy, in 40 infants with hypoplastic left heart syndrome (HLHS).

The study is being conducted across 12 premier pediatric sites in the United States with the support of the National Heart, Lung, and Blood Institute (NHLBI).

The primary endpoint focuses on the change in right ventricular ejection fraction, a critical measure of heart function in children born with an underdeveloped left side of the heart.

The program has gained significant attention from the medical community due to results from the preceding ELPIS I study, which showed 100% transplant-free survival until at least age five in the children treated with the therapy.

Currently, children with HLHS must undergo a series of three high-risk open-heart surgeries, and many still face the eventual need for a heart transplant.

Laromestrocel has been granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations by the FDA, reflecting the urgent unmet need in this patient population.

Longeveron is also exploring the utility of its Lomecel-B platform in other aging-related conditions and specialized inflammatory diseases.

However, the August readout for HLHS is viewed by analysts as the company's most significant near-term valuation catalyst, as positive Phase 2b data could pave the way for an accelerated regulatory filing and provide the first validation of MSC therapy in pediatric cardiac care.