Longeveron Inc Stock Price, News & Analysis

Longeveron (NASDAQ: LGVN) announced that Co‑founder and Chief Science Officer Dr. Joshua Hare was interviewed on NPR’s BioTech Nation about hypoplastic left heart syndrome (HLHS) and Longeveron’s investigational stem cell therapy, laromestrocel. The company said its pivotal Phase 2b trial ELPIS II is fully enrolled and top‑line results are anticipated in Q3 2026. ELPIS II follows ELPIS I, where treated children experienced 100% transplant‑free survival to five years versus an approximate 20% mortality rate from historical controls. The trial is conducted with NHLBI via NIH grants. The FDA previously designated laromestrocel as Orphan Drug, Fast Track, and Rare Pediatric Disease, and in August 2024 confirmed ELPIS II as a pivotal trial that could support a BLA if efficacy is demonstrated.

Longeveron (NASDAQ: LGVN) will participate in the 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025 in New York.

Management will hold one-on-one investor meetings during the conference to discuss the company's clinical-stage cellular therapy programs for rare pediatric and aging-related conditions.

Longeveron (NASDAQ: LGVN), a clinical stage biotechnology company, has appointed Dr. George Paletta, Jr. to its Board of Directors. Dr. Paletta brings extensive experience as an orthopedic surgeon, entrepreneur, and investor, having participated in ASC deals totaling nearly $1 billion.

Dr. Paletta joins Longeveron at a crucial time as the company advances its stem cell therapy pipeline, including a fully enrolled pivotal clinical trial in HLHS with data expected in 2026. The company focuses on developing cellular therapies for life-threatening rare pediatric and chronic aging-related conditions.

As the St. Louis Cardinals' head team doctor, Dr. Paletta holds multiple patents in orthopedic and cardiovascular fields and has founded Preston Worldwide, a medical device company. He completed his medical education at Johns Hopkins and holds an MBA from Washington University's Olin School of Business.

Longeveron (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 6-8, 2025 in Phoenix, Arizona. The company will explore potential partnerships for its Alzheimer's disease stem cell therapy program, laromestrocel.

The company's Phase 2a clinical trial (CLEAR MIND) demonstrated positive results, showing an overall slowing of disease progression compared to placebo. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for mild Alzheimer's treatment. Following a positive Type B meeting with the FDA in March 2025, alignment was reached on a single, pivotal Phase 2/3 clinical trial design that could support BLA submission.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, announced significant leadership changes. Than Powell, previously Chief Business Officer, has been appointed as interim CEO, replacing Wa'el Hashad who is stepping down. Additionally, Dr. Joshua Hare, co-founder and Chief Science Officer, has been appointed as Executive Chairman of the Board.

The company's stem cell therapy laromestrocel has shown positive initial outcomes in five clinical trials across three indications. Their pivotal Phase 2b trial for HLHS has achieved full enrollment, with top-line results expected in 2026. The company has expanded its pipeline to include pediatric dilated cardiomyopathy, marking their third program in pivotal clinical trials.

Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotech company, will present at the H.C. Wainwright 27th Annual Global Investment Conference in New York City. The presentation is scheduled for Monday, September 8, 2025, from 4:00 to 4:30 p.m. ET.

The company, which focuses on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, will make the presentation available via webcast. Investors can access the webcast through the "Events and Presentations" section of Longeveron's website, with replay access available for 180 days following the conference.

Longeveron (NASDAQ: LGVN) reported Q2 2025 financial results and provided updates on its cell therapy programs. The company achieved full enrollment in its pivotal Phase 2b ELPIS II trial for HLHS (Hypoplastic Left Heart Syndrome), with top-line results expected in Q3 2026. The FDA confirmed ELPIS II as pivotal for potential BLA submission in late 2026.

Financial highlights include revenues of $0.7 million (down 31% YoY), increased R&D expenses to $5.5 million (up 39%), and a net loss of $10.0 million. Cash position stands at $10.3 million, expected to fund operations into Q1 2026.

The company expanded its pipeline with FDA approval of an IND for laromestrocel in Pediatric Dilated Cardiomyopathy and reported positive FDA interactions regarding its Alzheimer's disease program pathway.

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.