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Longeveron Announces Constructive Type C Meeting with U.S. FDA Ahead of Data Readout for ELPIS II Phase 2b Clinical Trial Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)

Barchart·05/08/2026 15:05:00
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MIAMI, May 08, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that a constructive Type C meeting with the U.S. Food and Drug Administration (FDA or Agency) was held in late March, with the FDA providing their meeting summary in late April, to discuss the ongoing development of laromestrocel (LOMECEL-B®), a proprietary, scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (ELPIS II) for hypoplastic left heart syndrome (HLHS). Top-line results from the randomized, controlled Phase 2b ELPIS II clinical trial are anticipated in August 2026.

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