RegulatoryCompany release

Longeveron's HLHS cell therapy misses primary endpoint but shows fewer major cardiac events in ELPIS II

🇺🇸 Longeveron Inc. (LGVN) · Mon 26 Oct 2026

Laromestrocel did not improve right ventricular ejection fraction at 12 months, though a prespecified secondary analysis found one major adverse cardiac event against eight with standard care.

Longeveron has reported further analysis of ELPIS II, its Phase 2b trial of laromestrocel, an investigational stem cell therapy for infants with hypoplastic left heart syndrome (HLHS). The study enrolled 40 infants, and the therapy was given during Stage 2 surgery.

The trial missed its primary endpoint, the change in right ventricular ejection fraction (RVEF) at month 12. The company did not provide further detail on that result in the material available.

A prespecified secondary endpoint, major adverse cardiac events, pointed the other way. One event occurred in the laromestrocel arm, compared with eight in the standard-of-care arm (P=0.043).

Longeveron said it intends to ask the US Food and Drug Administration for a meeting to discuss next steps. The full data will be presented at the American Heart Association (AHA) Scientific Sessions on 8 November 2026.

What it means for your team

  • The primary endpoint was missed, so any development path would rest on a prespecified secondary endpoint. Regulators will probably look closely at how that result is interpreted.
  • The planned FDA meeting is the key step to watch, as it should show whether the agency sees a route forward after this trial.
  • Safety and event-adjudication details, expected at the AHA presentation on 8 November, will matter for pharmacovigilance and clinical teams assessing the signal.
  • Market-access teams should treat the findings as preliminary: the therapy remains investigational and no regulatory path has been confirmed.

Company's press release (SEC filing): Longeveron Inc. ↗

Article written by VigiEye from the official source (Longeveron Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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