Longeveron Inc. (LGVN) said Wednesday that the U.S. Food and Drug Administration has granted Fast Track designation to Lomecel-B for the treatment of mild Alzheimer's Disease.
In pre-market, the shares were gaining 27.55 percent to trade at $4.49.
The FDA's Fast Track designation process is designed to facilitate the development and expedite the review of new therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Investigational therapies that receive Fast Track designation may be eligible for Priority Review if relevant criteria are met at the time of application submission to FDA, and rolling FDA review.
The Fast Track designation granted to the Lomecel-B Alzheimer's Disease program is the fifth special regulatory designation received for Lomecel-B. The Lomecel-B Alzheimer's Disease program has also been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, while the Lomecel-B HLHS program has received three FDA designations: Orphan Drug designation, Fast Track designation and Rare Pediatric Disease designation.
Lomecel-B is a proprietary, scalable, allogeneic, investigational cellular 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 ongoing).
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