Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)
Longeveron Inc. announced a positive Type C meeting with the FDA, advancing Lomecel-B™ for HLHS treatment. ELPIS II trial may lead to BLA submission, following ELPIS I's success. Lomecel-B™, derived from MSCs, shows promise for cardiac regenerative therapy. HLHS affects 1,000 U.S. infants annually, with current treatments offering limited survival rates.
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Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)
Longeveron Inc. announced a positive Type C meeting with the FDA, advancing Lomecel-B™ for HLHS treatment. ELPIS II trial may lead to BLA submission, following ELPIS I's success. Lomecel-B™, derived from MSCs, shows promise for cardiac regenerative therapy. HLHS affects 1,000 U.S. infants annually, with current treatments offering limited survival rates.