Longeveron explores strategic options after therapy fails mid-stage trial for infant heart condition
Longeveron explores strategic options after therapy fails mid-stage trial for infant heart condition Sept 17 (Reuters) - Longeveron LGVN.O 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 to 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.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Jonathan Ananda)
((Kamal.Choudhury@thomsonreuters.com;))