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Laromestrocel (Lomecel-B™)

Hypoplastic Left Heart Syndrome (HLHS)

Phase 2bActive, Fully Enrolled - ELPIS II trial

Key Facts

Indication
Hypoplastic Left Heart Syndrome (HLHS)
Phase
Phase 2b
Status
Active, Fully Enrolled - ELPIS II trial
Company

About Longeveron

Longeveron Inc. is a Miami-based biotech focused on developing regenerative cellular therapies to improve healthspan by targeting chronic, aging-related diseases and life-threatening conditions. Its core achievement is the advancement of laromestrocel (Lomecel-B™), an allogeneic MSC therapy, into late-stage trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, supported by key regulatory designations like RMAT and Fast Track. The company's strategy leverages a vertically integrated manufacturing platform and pursues high-unmet-need indications with a multi-modal therapeutic hypothesis, aiming for near-term pivotal data in 2026 to drive potential BLA submissions.

View full company profile

About Longeveron

Longeveron Inc. is a Miami-based biotech focused on developing regenerative cellular therapies to improve healthspan by targeting chronic, aging-related diseases and life-threatening conditions. Its core achievement is the advancement of laromestrocel (Lomecel-B™), an allogeneic MSC therapy, into late-stage trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, supported by key regulatory designations like RMAT and Fast Track. The company's strategy leverages a vertically integrated manufacturing platform and pursues high-unmet-need indications with a multi-modal therapeutic hypothesis, aiming for near-term pivotal data in 2026 to drive potential BLA submissions.

View full company profile

About Longeveron

Longeveron Inc. is a Miami-based biotech focused on developing regenerative cellular therapies to improve healthspan by targeting chronic, aging-related diseases and life-threatening conditions. Its core achievement is the advancement of laromestrocel (Lomecel-B™), an allogeneic MSC therapy, into late-stage trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, supported by key regulatory designations like RMAT and Fast Track. The company's strategy leverages a vertically integrated manufacturing platform and pursues high-unmet-need indications with a multi-modal therapeutic hypothesis, aiming for near-term pivotal data in 2026 to drive potential BLA submissions.

View full company profile

About Longeveron

Longeveron Inc. is a Miami-based biotech focused on developing regenerative cellular therapies to improve healthspan by targeting chronic, aging-related diseases and life-threatening conditions. Its core achievement is the advancement of laromestrocel (Lomecel-B™), an allogeneic MSC therapy, into late-stage trials for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer's disease, supported by key regulatory designations like RMAT and Fast Track. The company's strategy leverages a vertically integrated manufacturing platform and pursues high-unmet-need indications with a multi-modal therapeutic hypothesis, aiming for near-term pivotal data in 2026 to drive potential BLA submissions.

View full company profile