Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Longeveron Inc. - Class A Common stock (LGVN)
Company Research
Source: GlobeNewswire
ELPIS II top-line trial results are anticipated in the third quarter of 2026Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designationLaromestrocel HLHS program has the potential to address an unmet medical need with significant U.S. market opportunitiesEven with current standard of care surgeries, only 50% of infants survive to adolescence due to right ventricular failure MIAMI, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout
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- Longeveron Inc. (LGVN) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- Longeveron Announces 2025 Full Year Financial Results and Provides Business UpdateGlobeNewswire
- Earnings To Watch: Longeveron Inc (LGVN) Reports Q4 2025 Results [Yahoo! Finance]Yahoo! Finance
LGVN
Earnings
- 3/17/26 - Miss
LGVN
Sec Filings
- 3/25/26 - Form 8-K
- 3/25/26 - Form D
- 3/24/26 - Form 8-K
- LGVN's page on the SEC website