Longeveron, Inc
Longeveron (LGVN) is a clinical-stage biotechnology company developing a cellular therapy, laromestrocel, which has delivered several positive initial results across 5 clinical trials in 3 indications: Phase 1 & 2 in Alzheimer’s Disease, Phase 1 & 2 in Aging-related Frailty, Phase 1 in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease.
The Company is nearing completion of enrollment for its pivotal Phase 2 clinical trial for HLHS, which, if positive, would be the foundation for a Biological License Application (BLA) submission.
Positive Phase 2 data in Alzheimer's disease was recently selected for publication in Nature Medicine. In a recent Type B meeting, the company and the FDA reached foundational agreement on the development pathway in Alzheimer's disease, which allows the company to conduct a single, pivotal Phase 3 clinical trial to support a potential BLA for this additional indication.
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