Zacks Small Cap Research – LGVN Gets Great FDA News for Alzheimer’s Drug – Technologist

By Brad Sorensen, CFA

NASDAQ:LGVN

READ THE FULL LGVN RESEARCH REPORT

Longeveron (NASDAQ:LGVN) announced that its primary treatment, Lomecel-B, has been granted Fast Track designation by the FDA only a week after being granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for the treatment of Alzheimer’s Disease. These two developments add to the designations received from the FDA that include Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for Lomecel-B the treatment of hypoplastic left heart syndrome (HLHS), which we’ve written extensively about before.

Fast Track designation is granted by the FDA to facilitate the expedited development and review of new drugs that are intended to treat serious or life-threatening conditions, while demonstrating the potential to address unmet medical needs (FDA.gov). This further demonstrates the potential the FDA believes Lomecel-B has in treating the millions of patients suffering from Alzheimer’s Disease.

As a reminder, the RMAT designation, which was granted last week, is a fairly recent one, created when the 21st Century Cures Act was passed. The designation is designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies, which Lomecel-B is. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. This new designation is similar to the longer-standing Breakthrough Therapy designation and provides the benefits of intensive FDA guidance on efficient drug development It includes the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

Alzheimer’s Disease is a devastating disease for millions of people and their families, with the Alzheimer’s Association estimating nearly seven million people suffering from the condition at the present time, with that number expected to grow substantially in the coming years. There have been several high-profile FDA approvals for treatments of Alzheimer’s at various stages and with limited impacts. That’s not to denigrate any existing treatment but point out that even the companies with the approved drugs believe there is much more work to do. The clinical results for Lomecel-B are detailed below and we have believed the results were very encouraging and are pleased to see the FDA further recognize the potential the treatment has.

The company recently announced that its CLEAR MIND Phase 2a trial evaluating Lomecel-B in mild Alzheimer’s Disease has been accepted for a Featured Research Session Oral Presentation at the 2024 Alzheimer’s Association International Conference. As a reminder, those results include:

• The primary endpoint of the study of safety was met across all study groups.

• The company also reported that Lomecel-B improved cognitive function, while caregivers documented improved quality of life in Lomecel-B treated patients with Alzheimer’s disease. Additionally, the company noted that MRI Biomarker data showed that “Lomecel-B countered loss of brain volume in multiple areas associated with Alzheimer’s disease.”

This announcement from the FDA about the Fast Track designation after announcing the RMAT designation further encourages our optimism about the potential for Lomecel-B to positively impact those suffering from Alzheimer’s and raises the possibility of finding a strategic partner that will help Longeveron bring this badly needed treatment to market.

Summary

We continue to believe that Longeveron is an exciting clinical-stage company and investors aren’t appropriately appreciating the game-changing potential Lomecel-B may be able to have on multiple serious medical conditions. As a result of the prudent decisions made by management, we believe Lomecel-B will ultimately have a substantial impact on the health situations of thousands of patients. We believe the stock continues to be underpriced as investors aren’t appreciating the potential of Lomecel-B and encourage investors to take a look at LGVN.

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