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. - 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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News
- Longeveron Applauds Passage of the Mikaela Naylon Give Kids a Chance Act and Reauthorization of Rare Pediatric Disease Priority Review Voucher ProgramGlobeNewswire
- Longeveron® Granted Japan Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells (MSCs)GlobeNewswire
- 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) [Yahoo! Finance]Yahoo! Finance
- Longeveron, Selected as a StartUp Health Alzheimer's Disease Moonshot Company, Will Participate in StartUp Health Apollo House During JPM Healthcare Week 2026 [Yahoo! Finance]Yahoo! Finance
- Longeveron, Selected as a StartUp Health Alzheimer’s Disease Moonshot Company, Will Participate in StartUp Health Apollo House During JPM Healthcare Week 2026GlobeNewswire
LGVN
Earnings
- 11/4/25 - Miss
LGVN
Sec Filings
- 1/6/26 - Form 4
- 1/6/26 - Form 4
- 1/6/26 - Form 4
- LGVN's page on the SEC website