Welcome to our dedicated page for Longeveron news (Ticker: LGVNR), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.
Longeveron Inc. (LGVNR) is a clinical-stage biotechnology pioneer developing cellular therapies for chronic conditions including Alzheimer’s disease, aging-related frailty, and congenital heart defects. This dedicated news hub provides investors and stakeholders with essential updates on the company’s scientific advancements and regulatory progress.
Access timely reports on clinical trial developments, FDA designations like Regenerative Medicine Advanced Therapy (RMAT), and strategic collaborations. Our curated collection features press releases about therapeutic innovations, peer-reviewed research publications, and milestone achievements in Longeveron’s pipeline.
Key content areas include updates on the company’s allogeneic stem cell therapies, progress across Phase 1/2 trials, and analyses of market-moving developments. Each update is vetted for relevance to long-term investors and researchers tracking cellular medicine breakthroughs.
Bookmark this page for streamlined access to LGVNR’s latest verified announcements. For comprehensive tracking of this innovative biotech’s journey in regenerative medicine, revisit regularly as new information becomes available.
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.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has appointed Than Powell as Chief Business Officer, effective July 7, 2025. Powell will lead the company's business strategy, focusing on Alzheimer's disease program partnering and international strategy for the hypoplastic left heart syndrome (HLHS) program.
Powell brings over 25 years of pharmaceutical and biotech leadership experience from companies including GSK and Eli Lilly. The appointment comes at a crucial time as Longeveron recently completed enrollment in its pivotal Phase 2 trial for laromestorcel, with top-line data expected in approximately 13 months. If positive, these results would support the company's first Biological License Application (BLA) submission.
Longeveron (NASDAQ:LGVN) has completed enrollment for its pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a treatment for Hypoplastic Left Heart Syndrome (HLHS). The trial enrolled 40 pediatric patients across 12 premier institutions, with top-line results expected in Q3 2026.
The therapy has received Rare Pediatric Disease, Orphan Drug, and Fast Track designations from the FDA. The ELPIS II trial builds on positive ELPIS I results, which showed 100% transplant-free survival up to five years post-treatment, compared to historical control data showing 20% mortality. If approved, the U.S. market potential is estimated at up to $1 billion.
Upon potential FDA approval, Longeveron could receive a Priority Review Voucher, which recently sold for $150-$158 million.
Longeveron (NASDAQ: LGVN) announced its participation in the BIO International Convention 2025 in Boston, where management will explore partnership opportunities for its Alzheimer's disease program. The company's lead candidate laromestrocel, a proprietary allogenic cellular therapy, has shown promising results in Phase 1 and 2 trials. The Phase 2a CLEAR MIND trial demonstrated significant improvements in clinical and biomarker endpoints compared to placebo, with results published in Nature Medicine in March 2025.
Following a Type B meeting with the FDA, Longeveron received alignment on a planned single, pivotal Phase 2/3 clinical trial, which could support a Biological License Application (BLA) if positive. The trial is expected to initiate in 2H 2026, subject to non-dilutive funding or partnership support. Notably, laromestrocel is reportedly the first cellular therapeutic to receive both FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for mild Alzheimer's disease.
Longeveron (NASDAQ: LGVN) has been selected as a Semi-Finalist and received a $250,000 Milestone 1 Award in the XPRIZE Healthspan competition, a $101 million global initiative aimed at revolutionizing human aging treatment. The company's stem cell therapy laromestorcel has shown positive initial results across 5 clinical trials in 3 indications: Alzheimer's Disease, Aging-related Frailty, and Hypoplastic Left Heart Syndrome (HLHS).
The therapy has received five FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, plus RMAT and Fast Track designations for Alzheimer's Disease. As a semifinalist, Longeveron is now eligible to compete for a $1 million milestone prize and a grand prize ranging from $61-81 million.
Longeveron (NASDAQ: LGVN) reported its Q1 2025 financial results and provided updates on its laromestrocel stem cell therapy development. The company's pivotal Phase 2b ELPIS II trial for Hypoplastic Left Heart Syndrome (HLHS) has reached 95% enrollment and is expected to complete in Q2 2025, with potential BLA submission in 2026. Results from the Phase 2a CLEAR MIND trial for Alzheimer's disease were published in Nature Medicine, and the FDA has approved a single, pivotal Phase 2/3 adaptive design trial pathway.
Financial highlights include: revenues of $0.4M (down 30% YoY), net loss of $5.0M (up 23% YoY), and cash position of $14.3M, expected to fund operations into Q3 2025. The company plans to seek additional financing to support BLA enabling activities and is pursuing partnership opportunities for its Alzheimer's program.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has scheduled its first quarter 2025 financial results announcement and business update for May 8, 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 1.877.407.0789 with Conference ID 13752361. An archived replay will be available on the company's website following the event.
Longeveron (NASDAQ: LGVN) has issued a shareholder letter highlighting its progress in 2024 and objectives for 2025. The company's lead product, laromestrocel (Lomecel-B™), is advancing in clinical trials for multiple indications.
Key developments include:
- Nearly 95% enrollment completion in the HLHS Phase 2b ELPIS II trial, with completion expected in Q2 2025
- FDA confirmation that ELPIS II could be considered pivotal for BLA submission
- Positive results in Alzheimer's disease Phase 2a CLEAR MIND trial
- FDA alignment on single, pivotal Phase 2/3 trial design for Alzheimer's program
The company estimates market opportunities of ~$5+ billion for Alzheimer's disease, ~$4+ billion for Aging-related Frailty, and up to ~$1 billion for HLHS. Current cash is projected to fund operations into Q4 2025, though accelerated BLA activities may impact this timeline. The company is seeking additional financing and strategic partnerships.
