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Longeveron (NASDAQ:LGVN) shares climbed in the morning hours Wednesday after the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for its lead asset Lomecel-B as a treatment for mild Alzheimer’s.
Targeted at regenerative medicines, including cell therapies such as Lomecel-B, the RMAT designation offers regulatory benefits similar to the FDA’s breakthrough therapy designation, helping developers bring their products to markets faster.
“The RMAT designation is an important milestone for Longeveron and the Lomecel-B™ program that recognizes the potential of our cellular therapy to have a positive impact on patients afflicted with this devastating disease,” said Joshua Hare, LGVN’s science chief and co-founder.
Longeveron (LGVN) has already completed a Phase 2a trial called CLEAR MIND for Lomecel-B, which reached the main goals in patients with mild Alzheimer’s disease, according to topline data announced in October.
The company expects to release full trial results at an Alzheimer’s-focused medical event in July.