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. (symbol: LGVN) is a clinical-stage biotechnology company at the forefront of regenerative medicine. The company is dedicated to developing innovative cellular therapeutics to address unmet medical needs related to aging and life-threatening conditions. Longeveron's lead investigational product, Lomecel-B™, is an advanced stem cell formulation derived from the bone marrow of young, healthy adult donors. This allogeneic (‘off-the-shelf’) product is currently being investigated for its potential to promote tissue repair and healing.
Lomecel-B™ is being explored for three primary indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease (AD), and Aging-related Frailty. The unique mechanisms of action of Lomecel-B™, which include stimulating new blood vessel formation, modulating the immune system, reducing tissue fibrosis, and promoting the division of endogenous cells, make it a promising candidate for these conditions.
In its HLHS program, Longeveron has seen remarkable results. A Phase 1 trial showcased a 100% transplant-free survival rate at up to five years of age, a significant milestone considering the fatality and transplant rates historically associated with this rare pediatric disease. The ongoing Phase 2 trial aims to compare outcomes of standard care plus Lomecel-B™ vs. standard care alone, with an eye towards accelerated or final approval from the FDA based on these promising results.
For Alzheimer’s Disease, Longeveron has completed a Phase 2a CLEAR-MIND trial involving 49 patients, building on the success of its initial Phase 1 trial. Encouraging efficacy signals from this study are driving the company to seek partnerships and funding to advance this program further, addressing a vast unmet need with potential significant market opportunities.
On the financial front, Longeveron is actively managing expenses and seeking additional capital, crucial for continuing its operations and funding its ambitious pipeline. The company has undertaken measures such as a reverse stock split and filing a registration statement with the SEC to facilitate capital raising. The company’s cash resources are currently insufficient to fund operations beyond the second quarter of 2024, highlighting the urgency of securing additional financing.
CEO Wa’el Hashad, marking his first anniversary with the company, emphasizes a strategic roadmap focused on leveraging Longeveron's scientific strengths while navigating the capital market environment. The company is also exploring revenue-generating activities like contract development and manufacturing services (CDMO) to bolster its financial position.
Longeveron's commitment to responsible financial stewardship and strategic operational goals positions it as a significant player in the regenerative medicine field. The company remains dedicated to bringing Lomecel-B™ to market, potentially transforming the treatment landscape for patients suffering from devastating conditions.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission on Lomecel-B™ has been selected for a late breaking poster presentation at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain. The presentation, titled 'Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease', will be held on October 29-30, 2024.
CEO Wa'el Hashad expressed excitement about presenting important Lomecel-B™ data at this leading Alzheimer's research forum, stating that the findings offer potential mechanistic and clinical insights for developing cellular-based therapy for Alzheimer's disease. The abstract will also be included in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease (JPAD), the official journal of the CTAD conference.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting. The presentation will showcase 5-year long-term survival data from the ELPIS I follow-on study, focusing on the potential of Lomecel-B™ as an adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).
The presentation is scheduled for Sunday, October 27, 2024, during the Scientific Session II. Longeveron's CEO, Wa'el Hashad, expressed excitement about sharing the data at this leading forum for congenital heart disease clinical investigation. The company is currently conducting the ELPIS II Phase 2b clinical trial, which may serve as the foundation for a BLA submission for potential approval of Lomecel-B™ if the results are positive.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, announced its participation in the UBS Virtual Organ Restoration and Cell Therapy Day on October 15, 2024. The company's CEO, Wa'el Hashad, will engage in a Fireside Chat with Ash Verma, SMID-cap Biotech & Specialty Pharma Analyst at UBS Equity Research.
The virtual event is scheduled for Tuesday, October 15, 2024, from 3:00 p.m. to 3:45 p.m. ET. Interested parties can register for the event by contacting their UBS representative. Additionally, Longeveron's investor presentation is available in the 'Events & Presentations' section of the company's website.
Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, positioning itself at the forefront of regenerative medicine research.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024 in New York City. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will be represented by Wa'el Hashad, Chief Executive Officer.
Hashad will be speaking on the panel 'Emerging Frontiers in Neuroscience' and will also be available for investor one-on-one meetings. Longeveron has made its investor presentation for the conference accessible in the 'Events & Presentations' section of the company's website, allowing interested parties to review the materials in advance.
Longeveron Inc. (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 7-9, 2024 in Phoenix, Arizona. The company aims to explore potential partnerships and strategic opportunities for its cellular therapy program in Alzheimer's disease, which has shown positive results in Phase 1 and Phase 2a clinical trials.
Longeveron will also highlight its contract development and manufacturing business at its 15,000 square feet facility with 8 cGMP cleanroom suites. The company's lead investigational therapeutic candidate, Lomecel-B™, has demonstrated promising results in the CLEAR MIND Phase 2a clinical trial for mild Alzheimer's disease. Lomecel-B™ has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA for this indication.
Longeveron (NASDAQ: LGVN) announced a positive Type C meeting with the FDA regarding the pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS). Key points include:
- The ongoing Phase 2b clinical trial (ELPIS II) may be deemed pivotal for BLA submission
- Alignment reached on primary and secondary endpoints for ELPIS II
- Agreement on Chemistry, Manufacturing and Controls (CMC) and Potency Assay plans
- ELPIS II builds on positive results from ELPIS I, which showed 100% transplant-free survival up to five years
- Lomecel-B™ has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations
The company views this as a significant step towards potential approval of Lomecel-B™ as an HLHS adjunct therapy.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled to take place from September 9-11, 2024 in New York City.
Longeveron's presentation is set for Tuesday, September 10, 2024, from 5:00 – 5:30 p.m. ET. Investors and interested parties can access the webcast through the "Events and Presentations" section of the company's website. A replay of the presentation will be available for 180 days following the conference.
This conference provides Longeveron with an opportunity to showcase its progress in developing cellular therapies for life-threatening and chronic aging-related conditions to a global investment audience.
Longeveron Inc. (NASDAQ: LGVN) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Positive data from Phase 2a CLEAR MIND trial for Lomecel-B™ in Alzheimer's disease presented at AAIC.
2. FDA granted RMAT and Fast Track designations for Lomecel-B™ in mild Alzheimer's disease.
3. Phase 2b ELPIS II trial for HLHS achieved 70% enrollment, targeting completion by end of 2024.
4. Total operating expenses reduced by 22% year-over-year in H1 2024.
5. Raised $15.3 million in July, extending cash runway through Q4 2025.
6. Revenues increased 105% to $1.0 million in H1 2024, driven by Bahamas Registry Trial and new contract manufacturing business.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced it will report its second quarter 2024 financial results on August 14, 2024, after the U.S. financial markets close. The company will also host a conference call and webcast at 4:30 p.m. ET on the same day to provide a business update. Investors can access the conference call via phone or webcast, with an archived replay available on the company's website afterward. Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions.
Longeveron (NASDAQ: LGVN) presented positive Phase 2a clinical trial results for Lomecel-B™ in mild Alzheimer's Disease at the Alzheimer's Association International Conference® (AAIC) 2024. The CLEAR MIND trial, involving 48 patients, demonstrated improved cognitive function, quality of life, and brain volume. Key findings include:
- Established safety profile with no hypersensitivity or infusion-related reactions
- Slowing of disease worsening compared to placebo
- Statistically significant improvements in cognitive assessments and daily living activities
- 49% reduction in brain volume loss
- Potential reduction in neuroinflammation
Lomecel-B™ has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for mild Alzheimer's Disease treatment.
FAQ
What is the current stock price of Longeveron (LGVN)?
What is the market cap of Longeveron (LGVN)?
What is Longeveron Inc.?
What is Lomecel-B™?
What conditions is Lomecel-B™ being investigated for?
How has Longeveron performed in its HLHS trials?
What are the financial challenges Longeveron faces?
What are the future plans for Longeveron's Alzheimer's Disease program?
How is Longeveron managing its financial position?
Who is the CEO of Longeveron?
What are Longeveron's core business objectives?
Where can I find more information about Longeveron?
