Longeveron Inc. Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy Designation for the Treatment of Mild Alzheimer’s Disease -…

Longeveron Inc. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for the treatment of mild Alzheimer?s Disease. Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer?s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer?s Disease.

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimer?s Association International Conference (AAIC) on July 28, 2024. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies.

A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

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Longeveron Inc. Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy Designation for the Treatment of Mild Alzheimer's Disease -...