Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to Lomecel-B(TM) for the treatment of mild Alzheimer’s Disease. Lomecel-B(TM) is a proprietary, scalable, allogeneic, investigational cellular therapy being evaluated across multiple indications. The Fast Track designation process aims 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. According to the announcement, the Fast Track designation granted to the Lomecel-B(TM) Alzheimer’s Disease program is the fifth special regulatory designation received for Lomecel-B(TM). “Fast Track designation is another important milestone for Longeveron and Lomecel-B(TM), which, along with the recent granting of Regenerative Medicine Advanced Therapy (“RMAT”) designation, recognizes the critical need for quickly advance novel, safe and effective investigational treatments for Alzheimer’s Disease, which has a devastating impact on patients and their families,” said, Wa’el Hashad, CEO of Longeveron.
To view the full press release, visit https://ibn.fm/iLqbj
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B(TM), an allogeneic medicinal signaling cell (“MSC”) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (“HLHS”), Alzheimer’s disease, and Aging-related Frailty. The Lomecel-B HLHS program has received three distinct and important U.S. FDA designations: Orphan Drug, Fast Track and Rare Pediatric Disease designations. For more information about the company, visit www.Longeveron.com.
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