Company announcementCompany-reported
What was reported
MIAMI, Fla., May 8, 2026 -- 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).U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · May 8, 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 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 SyndromeU.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · May 8, 2026 · Open the source ↗
Press release lead paragraphMIAMI, Fla., May 8, 2026 -- 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).U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · May 8, 2026 · Open the source ↗
Revision history
- Revision 1 · Oct 28, 2026, 20:51 UTC
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
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