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Shares of Longeveron Inc (NASDAQ:LGVN) are trading higher on Wednesday with a session volume of 78.36 million compared to the average volume of 8.34 million, as per data from Benzinga Pro.
The company announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for 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).
It means the treatment, made from cells that can be used in different patients, is also being tested for other conditions like age-related weakness and specific heart syndrome.
Related: What’s Going On With Longeveron Stock?
The company says that 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 in October 2023 and reported additional clinical data and imaging biomarker results in December 2023.
The RMAT designation is the fourth special regulatory designation received by Longeveron for Lomecel-B.
The Lomecel-B HLHS program has received FDA Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.
RMAT designation is a dedicated program to expedite a drug’s development and review processes for promising pipeline regenerative medicine products, including cell therapies.
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 the 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.
At one point, LGVN stock was up more than 100%.
Price Action: LGVN shares were up 62% at $4.66 at the last check on Wednesday.
Posted In: LGVN
