Longeveron receives FDA RMAT designation for Lomecel-B in mild Alzheimer's disease

Longeveron Inc.

FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B for mild Alzheimer's disease.
Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer's disease.
CLEAR MIND Phase 2a trial met primary safety and secondary efficacy endpoints; full results at AAIC on July 28, 2024.
This is the fourth special FDA designation for Lomecel-B; HLHS program holds Orphan Drug, Fast Track, and Rare Pediatric Disease designations.
RMAT designation enables intensive FDA guidance and potential expedited review and accelerated approval pathways.

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