Longeveron explores strategic options after therapy fails mid-stage trial for infant heart condition

Sept. 17 (Reuters) - Longeveron on Wednesday said it would explore strategic options after its experimental stem cell therapy failed to meet the main goal of a mid-stage trial for a rare infant heart condition.

Shares of the company, which have gained 32% so far this year, plunged nearly 60% in after-hours trading.

• The study tested the drug, laromestrocel, alongside standard surgery in 40 infants born with hypoplastic left heart syndrome, a severe birth defect where the left side of the heart is underdeveloped.
• The company said the study did not show the drug improving how well the right side of the heart pumped blood after 12 months compared with standard care alone.
• Over a 12-month period, there were no deaths among infants treated with laromestrocel compared with one death in the standard-care group, Longeveron said.
• In a subset of patients followed for up to five years, one death or heart-transplant event occurred among 17 patients in the treatment group, compared with two events among 21 patients in the standard-care group.
• Longeveron plans to review the data and meet with the U.S. Food and Drug Administration to discuss potential next steps for the program.
• The therapy was safe and well tolerated, with no new safety concerns identified, the company added.
• Longeveron said it has "initiated a process to review all options with the goal of maximizing shareholder value" while taking steps to cut costs.
• The company plans to shift resources toward developing the therapy for longevity and aging-related frailty.