Welcome to our dedicated page for Longeveron news (Ticker: LGVN), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.
Longeveron Inc (LGVN) is a clinical-stage biotechnology pioneer advancing regenerative therapies through mesenchymal stem cell research. This page provides centralized access to official news and press releases for investors tracking the company's progress in treating conditions like hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty.
Discover timely updates on clinical trial developments, regulatory milestones including FDA designations, and strategic partnerships. Our curated collection offers investors and researchers a reliable resource for understanding Longeveron's investigational product Lomecel-B and its applications in cellular therapeutics.
Key content includes updates on pediatric cardiac care advancements, neurodegenerative disease research breakthroughs, and manufacturing developments for allogeneic therapies. Bookmark this page to stay informed about critical updates affecting Longeveron's position in the regenerative medicine sector.
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.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced it will release its full-year 2024 financial results on Friday, February 28, 2025, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a business update. An archived replay will be available on the company's website following the conference.
Longeveron (NASDAQ: LGVN) announced that its cellular therapy Lomecel-B™ has received the International Non-proprietary Name (INN) 'laromestrocel' from the World Health Organization. Lomecel-B™ is being evaluated for Alzheimer's disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease.
The therapy has received multiple FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designation for mild Alzheimer's disease, as well as Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for HLHS treatment. The company has reported positive Phase 2a data in mild Alzheimer's disease and is nearing completion of enrollment for its Phase 2b HLHS clinical trial.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the upcoming Emerging Growth Virtual Conference. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will present on February 19, 2025, from 3:10 to 3:20 p.m. ET.
Interested parties can access the presentation through the 'Events and Presentations' section of Longeveron's website. The webcast replay will remain available for 180 days after the conference. Questions can be submitted in advance to Questions@EmergingGrowth.com or asked during the live event.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its upcoming participation at Biotech Showcase 2025. CEO Wa'el Hashad will deliver a corporate presentation on Tuesday, January 14, 2025, from 4:00 to 4:30 p.m. PT.
The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will make the presentation available via webcast through the 'Events and Presentations' section of their website. A replay will be accessible on Longeveron's website after the conference concludes.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the Emerging Growth Virtual Conference scheduled for December 4-5, 2024. The company will present on December 5, 2024, from 12:00 to 12:30 p.m. ET.
The presentation will be accessible through the company's website under the 'Events and Presentations' section, with the webcast replay available for 180 days following the conference. Participants can submit questions in advance to Questions@EmergingGrowth.com or during the event.
