Company announcementCompany-reported
What was reported
MIAMI, Fla., September 16, 2026 -- Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced topline results from ELPIS II, its Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS). The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12.U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 23, 2026 · Open the source ↗
What the evidence supports
Longeveron furnished a press release to the SEC (Form 8-K, Item 8.01) about a company announcement. It shows what the company chose to disclose on that date.
What remains unknown
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Source passages
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Press release headlineLongeveron Announces Topline Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 23, 2026 · Open the source ↗
Press release lead paragraphMIAMI, Fla., September 16, 2026 -- Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced topline results from ELPIS II, its Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome (HLHS). The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12.U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 23, 2026 · Open the source ↗
Revision history
- Revision 1 · Oct 28, 2026, 20:54 UTC
Longeveron Announces Topline Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)
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