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) 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.
Longeveron has achieved a positive Type B meeting with the FDA regarding the development pathway for laromestrocel (Lomecel-B) as a potential Alzheimer's disease treatment. The FDA agreed to consider a Biological License Application (BLA) based on a single, pivotal Phase 2/3 clinical trial's interim results.
The company has already completed two positive clinical trials in mild Alzheimer's patients: a Phase 1 study and the CLEAR-MIND Phase 2a trial. The latter demonstrated favorable safety, no amyloid-related imaging abnormalities, and improvements in cognition, function, quality of life, and reduced brain atrophy. These results led to FDA Regenerative Medicine Advanced Therapy (RMAT) designation.
The pivotal Phase 2/3 trial is planned for second half of 2026, subject to securing non-dilutive funding or partnership support. Laromestrocel has also received Fast Track designation and is reportedly the first cellular therapeutic candidate to receive RMAT designation for Alzheimer's disease.
Longeveron has published results from its Phase 2a CLEAR MIND clinical trial in Nature Medicine, evaluating laromestrocel (Lomecel-B™) for mild Alzheimer's disease treatment. The trial, involving 48 patients (36 treated, 12 placebo), demonstrated significant positive outcomes.
Key findings show the treatment:
- Improved cognitive function and quality of life
- Minimized brain volume loss in AD-associated areas
- Showed 20-30% reduction in ventricular enlargement
- Demonstrated safety and tolerability with no adverse reactions
The therapy achieved both primary safety and secondary efficacy endpoints, showing statistically significant improvements in Montreal Cognitive Assessment and Activities of Daily Living. Notably, laromestrocel is the first cellular therapeutic to receive FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease, along with Fast Track designation.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the 37th Annual Roth Conference scheduled for March 17-18, 2025. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will conduct a fireside chat during the event.
The presentation will be accessible through the 'Events and Presentations' section of Longeveron's website, with the webcast replay remaining available for 90 days after the conference.
Longeveron reported its full-year 2024 financial results, highlighting a 237% year-over-year increase in total revenue to $2.4 million. The company's pivotal Phase 2b clinical trial (ELPIS II) for Lomecel-B™ in treating Hypoplastic Left Heart Syndrome has achieved over 90% enrollment, with completion expected in Q2 2025.
Key financial metrics include a reduced net loss of $16.0 million (down 25% from 2023), with cash and equivalents of $19.2 million as of December 31, 2024. The company anticipates its current funds will support operations into Q4 2025.
Notable developments include WHO's approval of 'laromestrocel' as Lomecel-B's non-proprietary name and plans for a potential Biological License Application (BLA) submission in 2026. The company expects an FDA meeting in late Q1 2025 to discuss development paths for Lomecel-B in mild Alzheimer's disease.
