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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 (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.
Longeveron Inc. (NASDAQ: LGVN) has closed a $9.0 million registered direct offering priced at-the-market under Nasdaq rules. The company issued 2,236,026 shares of Class A common stock (or equivalents) at $4.025 per share. In a concurrent private placement, LGVN issued unregistered warrants to purchase up to 2,236,026 shares at $3.90 per share, exercisable for 24 months. H.C. Wainwright & Co. acted as the exclusive placement agent. Longeveron plans to use the net proceeds for clinical and regulatory development of Lomecel-B™, focusing on HLHS and Alzheimer's disease treatments, regulatory approvals, capital expenditures, and working capital.
Longeveron Inc. (NASDAQ: LGVN) has announced a $9.0 million registered direct offering priced at-the-market under Nasdaq rules. The company will issue and sell 2,236,026 shares of Class A common stock at $4.025 per share. Additionally, in a concurrent private placement, Longeveron will issue unregistered warrants to purchase up to 2,236,026 shares of Class A common stock at $3.90 per share, exercisable for 24 months.
The offering is expected to close on July 19, 2024. H.C. Wainwright & Co. is acting as the exclusive placement agent. Longeveron plans to use the net proceeds for clinical and regulatory development of Lomecel-B™, obtaining regulatory approvals, capital expenditures, working capital, and other corporate purposes.
Longeveron (NASDAQ: LGVN) has received Fast Track designation from the FDA for Lomecel-B™, its investigational cellular therapy for mild Alzheimer's Disease. This follows the recent Regenerative Medicine Advanced Therapy (RMAT) designation granted on July 9, 2024. The Fast Track status aims to expedite development and review of Lomecel-B™, recognizing its potential to address unmet medical needs in Alzheimer's treatment.
Lomecel-B™ demonstrated promising results in the CLEAR MIND Phase 2a clinical trial, showing an overall slowing/prevention of disease worsening compared to placebo. Full results from this trial will be presented at the upcoming Alzheimer's Association International Conference® (AAIC) in July 2024, including a Featured Research Session oral presentation and a poster presentation.
Longeveron announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for treating mild Alzheimer’s Disease. This makes Lomecel-B™ the first cellular therapeutic candidate to receive RMAT for Alzheimer’s. The therapy is being evaluated in multiple conditions, including Alzheimer’s (Phase 2a completed), Aging-related Frailty (Phase 2b completed), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 2b ongoing). The CLEAR MIND Phase 2a trial indicated that Lomecel-B™ slowed/prevented disease progression compared to placebo, meeting safety and efficacy endpoints. Full results will be presented in July 2024. RMAT designation aims to expedite the drug development process and offers benefits like FDA guidance and potential priority review.
Longeveron (NASDAQ: LGVN) has elected Neha Motwani to its Board of Directors during the Annual Meeting of Stockholders. Ms. Motwani brings over 25 years of healthcare investment banking experience, having raised approximately $7.0 billion in transactions while serving at firms like William Blair, Truist Securities, and Oppenheimer. Longeveron, a clinical-stage biotech company, is developing cellular therapies for conditions such as hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease. Co-founder Joshua Hare emphasized that her expertise in biopharma operations, financing, and capital markets will significantly benefit the company as it advances its Lomecel-B™ therapy, which has shown positive results in five clinical trials across three indications.
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