Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced a positive Type C meeting with the U.S. Food and Drug Administration (“FDA”). The meeting supported the advancement of Lomecel-B(TM), a proprietary, scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (“ELPIS II”) for hypoplastic left heart syndrome (“HLHS”). According to the announcement, Longeveron and the FDA reached foundational alignment on ELPIS II primary and secondary endpoints as well as on the need to submit the company’s prespecified Statistical Analysis Plan (“SAP”) and Chemistry, Manufacturing and Controls (“CMC”) readiness plan, including Lomecel-B(TM) stability and comparability data, for prior review.
“We are pleased to have alignment with FDA on the development pathway for our Lomecel-B(TM) development program in HLHS, which has a devastating impact on patients and their families,” commented Wa’el Hashad, CEO of Longeveron. “While we have a lot of work yet to do, the potential for ELPIS II to serve as the foundation for a BLA submission significantly reduces the time to reach submission and potential approval of Lomecel-B(TM) as an HLHS adjunct therapy.”
To view the full press release, visit https://ibn.fm/b8wNR
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.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN
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