Longeveron stock (NASDAQ: LGVN) surged during intraday trading Wednesday after the company achieved the FDA milestone with RMAT designation for its cellular therapy Lomecel-B™ in Alzheimer’s treatment.
Longeveron has achieved a significant milestone as its cellular therapy, Lomecel-B™, received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of mild Alzheimer’s Disease. This designation accelerates the development and review of promising regenerative therapies.
Lomecel-B™, derived from the bone marrow of young, healthy adult donors, is currently undergoing evaluation for various conditions, including Alzheimer’s Disease, Aging-related Frailty, and hypoplastic left heart syndrome (HLHS).
The therapy recently completed a Phase 2a clinical trial, CLEAR MIND, for Alzheimer’s Disease, where it met primary safety and secondary efficacy endpoints, showing promise in slowing or preventing the progression of the disease.
The RMAT designation, part of the 21st Century Cures Act, is reserved for therapies targeting serious conditions where early evidence suggests they can address unmet medical needs. It provides Longeveron with benefits such as intensive FDA guidance and the potential for expedited approval processes.
Statements from Longeveron Leadership
Joshua Hare, Co-founder, Chief Science Officer, and Chairman of the Board at Longeveron, emphasized the importance of this designation for advancing Lomecel-B™ as a therapeutic option for Alzheimer’s patients. He noted,
“Alzheimer’s Disease is a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. In the CLEAR MIND Phase 2a clinical trial, Lomecel-B™ demonstrated an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo.”
Longeveron plans to unveil comprehensive findings from the CLEAR MIND trial at the Alzheimer’s Association International Conference scheduled for July 28, 2024.
Longeveron (NASDAQ: LGVN) has received its fourth special regulatory designation for Lomecel-B™ with this RMAT designation. The HLHS program for Lomecel-B™ had previously secured three distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.
Wa’el Hashad, Chief Executive Officer and Board Member at Longeveron expressed satisfaction about receiving the RMAT designation, stating that it validates their work to date and facilitates crucial discussions with the FDA. He also emphasized that this designation will help advance their efforts and potentially bring this investigational therapeutic option to the many patients suffering from Alzheimer’s Disease.
Longeveron Stock (NASDAQ: LGVN) Reaction
LGVN stock soared 58.54% on Wednesday, closing at $4.55, marking a 170.83% increase for the week. The trading volume was 109,962,401 shares, significantly higher than the average daily volume of 10.22 million.
LGVN LGVN shares LGVN stock LGVN stock news Longeveron NASDAQ: LGVN
