Longeveron Inc Stock Price, News & Analysis

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has closed its previously announced public offering, raising $5.0 million in initial gross proceeds. The offering included 5,882,354 shares of Class A common stock (or pre-funded warrants) and short-term warrants to purchase up to 14,705,885 shares at $0.85 per share.

The offering, placed by H.C. Wainwright & Co., includes short-term warrants exercisable for 24 months that could generate an additional $12.5 million in gross proceeds if fully exercised. The funds will support clinical development of laromestrocel for treating HLHS, Alzheimer's disease, and pediatric DCM, along with regulatory approvals and BLA readiness activities.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, has announced a $17.5 million public offering. The offering consists of 5,882,354 shares of Class A common stock (or pre-funded warrants) at $0.85 per share, along with short-term warrants to purchase up to 14,705,885 additional shares.

The initial gross proceeds are expected to be $5.0 million, with potential additional proceeds of $12.5 million if all warrants are exercised. The warrants will have an exercise price of $0.85 per share and a 24-month exercise period. The funds will support clinical development of laromestrocel for treating HLHS, Alzheimer's disease, and pediatric DCM, along with regulatory approvals and BLA readiness.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, will release its Q2 2025 financial results on Wednesday, August 13, 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 telephone at 1.877.407.0789 using conference ID 13754295. A webcast replay will be available in the "Events & Presentations" section of Longeveron's website after the conference.

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), a clinical stage regenerative medicine biotech company, announced its participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference scheduled for June 16-17, 2025. CEO Wa'el Hashad will deliver a pre-recorded corporate presentation, which will be available on-demand starting Monday, June 16, at 7:00 a.m. ET. The presentation can be accessed through the company's website under the 'Events and Presentations' section, with the replay remaining available for 90 days following the conference. Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions.

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.