Longeveron Gets RMAT Designation For Lomecel-B In Alzheimer's Disease; Stock Up 60% In Pre-Market

(RTTNews) - Longeveron Inc. (LGVN) Wednesday said the Food and Drug Administration or FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for the treatment of mild Alzheimer's Disease. The stock was up more than 60 percent in pre-market.

Lomecel-B, the company's investigational allogeneic cellular therapy, is being evaluated in multiple indications. Phase 2a study and Phase 2b study of Lomecel-B are completed in Alzheimer's Disease and aging-related Frailty respectively. Phase 2b study of Lomecel-B in hypoplastic left heart syndrome is underway.

Longeveron had announced top-line results from the CLEAR MIND Phase 2a study showing slowing/prevention of disease worsening in patients treated with Lomecel-B compared to placebo. The trial had achieved the primary safety and secondary efficacy endpoints. RMAT designation provides the benefits of FDA guidance on efficient drug development, potential ways to support accelerated approval, and priority review of the biologics license application if Priority Review designation is granted following BLA submission.

Longeveron shares had closed at $2.87, up 38.65 percent on Tuesday. The stock has traded in the range of $0.7710 - 37.5000 in the last 1 year.