• Longeveron disclosed an independent Data Monitoring Committee review that found no new safety concerns in its fully enrolled Phase 2b ELPIS II trial of laromestrocel in hypoplastic left heart syndrome, supporting completion of the study as planned.
• Results have not yet been presented; top-line data are expected in August 2026.
• Review outcome reduces near-term clinical hold risk, keeping a key rare-disease program on track ahead of a pivotal readout.
• Trial enrolled 40 pediatric patients across 12 US cardiac centers, with NIH-backed funding support cited for the study.
• Laromestrocel holds FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations for hypoplastic left heart syndrome, which could support an accelerated regulatory path if efficacy data are positive.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Longeveron Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605110910PRIMZONEFULLFEED9717207) on May 11, 2026, and is solely responsible for the information contained therein.