By Brad Sorensen, CFA
NASDAQ:LGVN
READ THE FULL LGVN RESEARCH REPORT
Longeveron (NASDAQ:LGVN) is a company that should be getting more attention from investors and the just released annual results again proved that point. LGVN has made substantial progress with its signature treatment, Lomecel-B, in treating both HLHS and Alzheimer's Disease and we suggest investors take a look at this stock before more good news comes out—such as what happened recently.
Company management just announced that completed a “positive” Type B Meeting with the FDA regarding advancing Lomecel-B for the purpose of treating Alzheimer’s Disease. During the meeting, the FDA and the company reached alignment on the study design for a single, pivotal, seamless adaptive Phase 2/3 clinical trial. Additionally, something we always like to hear about the approval process, the FDA agreed to consider a Biological License Application (BLA) based on positive interim trial results, which accelerate the path to what we believe will be the approval of Lomocel-B as a treatment for Alzheimer’s.
As a reminder, our optimism is well founded based on trial results that we’ve written about recently. For example, the Phase 2a CLEAR-MIND study results showed a favorable safety profile, absence of amyloid-related imaging abnormalities (ARIA) with Lomecel-B TM administration, and several domains of potential clinical efficacy, including cognition, function, quality of life, and reduction in brain atrophy. The results of the CLEAR-MIND trial formed the basis for the FDA RMAT designation. Another reminder that the RMAT designation is an important milestone, allowing the company better access to the FDA and accelerating the pathway to approval.
In another piece of good news for investors, the company is planning to initiate the clinical trial in the second half of 2026—contingent on additional non-dilutive funding and/or development of a partnership.
The company has previously announced that Lomecel-B has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization. This was an important step in the commercialization potential of Lomecel-B and followed the therapy being the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease.
This announcement is very encouraging and supports what we’ve been writing about—that LGVN is making great strides and has the potential to impact patients experiencing difficult diseases such as Alzheimer’s Disease and HLHS, which we’ve written extensively and have received positive news on in recent months.
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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