Longeveron receives FDA Fast Track designation for Lomecel-B in mild Alzheimer's

Longeveron Inc.

FDA Fast Track designation granted for Lomecel-B (allogeneic cell therapy) to treat mild Alzheimer’s disease.
Second FDA special designation for Lomecel-B in Alzheimer's, following RMAT designation on July 9, 2024.
Fast Track enables Priority Review (6-month review) and rolling submission; fifth overall special designation.
Phase 2a CLEAR MIND data showed overall slowing/prevention of disease worsening versus placebo.
Full results to be presented at AAIC 2024 (July 28–Aug 1) in Featured Research Session and poster.

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