Longeveron Inc Stock Price, News & Analysis

Longeveron (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 6-8, 2025 in Phoenix, Arizona. The company will explore potential partnerships for its Alzheimer's disease stem cell therapy program, laromestrocel.

The company's Phase 2a clinical trial (CLEAR MIND) demonstrated positive results, showing an overall slowing of disease progression compared to placebo. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for mild Alzheimer's treatment. Following a positive Type B meeting with the FDA in March 2025, alignment was reached on a single, pivotal Phase 2/3 clinical trial design that could support BLA submission.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, announced significant leadership changes. Than Powell, previously Chief Business Officer, has been appointed as interim CEO, replacing Wa'el Hashad who is stepping down. Additionally, Dr. Joshua Hare, co-founder and Chief Science Officer, has been appointed as Executive Chairman of the Board.

The company's stem cell therapy laromestrocel has shown positive initial outcomes in five clinical trials across three indications. Their pivotal Phase 2b trial for HLHS has achieved full enrollment, with top-line results expected in 2026. The company has expanded its pipeline to include pediatric dilated cardiomyopathy, marking their third program in pivotal clinical trials.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, will present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City. The presentation is scheduled for Monday, September 8, 2025, from 4:00 to 4:30 p.m. ET.

The company, which focuses on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, will make the presentation available via webcast. Investors can access the webcast through the "Events and Presentations" section of Longeveron's website, with replay access available for 180 days following the conference.

Longeveron (NASDAQ: LGVN) reported Q2 2025 financial results and provided updates on its cell therapy programs. The company achieved full enrollment in its pivotal Phase 2b ELPIS II trial for HLHS (Hypoplastic Left Heart Syndrome), with top-line results expected in Q3 2026. The FDA confirmed ELPIS II as pivotal for potential BLA submission in late 2026.

Financial highlights include revenues of $0.7 million (down 31% YoY), increased R&D expenses to $5.5 million (up 39%), and a net loss of $10.0 million. Cash position stands at $10.3 million, expected to fund operations into Q1 2026.

The company expanded its pipeline with FDA approval of an IND for laromestrocel in Pediatric Dilated Cardiomyopathy and reported positive FDA interactions regarding its Alzheimer's disease program pathway.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has closed its previously announced public offering, raising $5.0 million in initial gross proceeds. The offering included 5,882,354 shares of Class A common stock (or pre-funded warrants) and short-term warrants to purchase up to 14,705,885 shares at $0.85 per share.

The offering, placed by H.C. Wainwright & Co., includes short-term warrants exercisable for 24 months that could generate an additional $12.5 million in gross proceeds if fully exercised. The funds will support clinical development of laromestrocel for treating HLHS, Alzheimer's disease, and pediatric DCM, along with regulatory approvals and BLA readiness activities.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has announced a $17.5 million public offering. The offering consists of 5,882,354 shares of Class A common stock (or pre-funded warrants) at $0.85 per share, along with short-term warrants to purchase up to 14,705,885 additional shares.

The initial gross proceeds are expected to be $5.0 million, with potential additional proceeds of $12.5 million if all warrants are exercised. The warrants will have an exercise price of $0.85 per share and a 24-month exercise period. The funds will support clinical development of laromestrocel for treating HLHS, Alzheimer's disease, and pediatric DCM, along with regulatory approvals and BLA readiness.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, will release its Q2 2025 financial results on Wednesday, August 13, 2025 after market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day.

Investors can access the conference call via telephone at 1.877.407.0789 using conference ID 13754295. A webcast replay will be available in the "Events & Presentations" section of Longeveron's website after the conference.

Longeveron (NASDAQ: LGVN) has licensed US Patent 12,168,028 B2 from the University of Miami, acquiring technology for deriving GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells. This breakthrough addresses a significant challenge in cardiovascular stem cell therapy by eliminating the risk of malignant ventricular arrhythmias associated with traditional induced pluripotent stem (iPS) cells.

The patented technology selectively produces cells destined to become cardiomyocytes while eliminating cells with electrical automaticity, potentially offering safer therapeutic solutions for various heart conditions. This advancement complements Longeveron's existing pipeline, which includes programs in hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and pediatric dilated cardiomyopathy.

Longeveron (NASDAQ: LGVN) has received FDA approval for its Investigational New Drug (IND) application to conduct a Phase 2 pivotal registration study of laromestrocel for treating pediatric dilated cardiomyopathy (DCM). The trial is expected to begin in the first half of 2026.

Laromestrocel, a proprietary allogeneic cell therapy derived from mesenchymal stem cells, aims to address a critical unmet need in DCM treatment, where nearly 40% of children require heart transplants or die within two years of diagnosis. The condition affects at least 100,000 children worldwide, with DCM being the most common form of cardiomyopathy in children, representing 50-60% of all pediatric cardiomyopathy cases.

The FDA's approval allows Longeveron to proceed directly to a Phase 2 pivotal registration trial, potentially accelerating the development timeline for this innovative stem cell therapy approach to treating pediatric cardiovascular diseases.