Longeveron Supports Congress Passing Kids Act

Longeveron supports and applauds Congress passing the Mikaela Naylon Give Kids a Chance Act. The Mikaela Naylon Give Kids a Chance Act reauthorizes the Rare Pediatric Disease Priority Review Voucher Program, which encourages the development of treatments for rare pediatric diseases. Companies pursuing treatments for rare pediatric diseases can receive a priority review voucher upon FDA approval of a therapy, and then either use it to secure a speedier FDA review of a future therapy or sell it to another company. Since August 2024, vouchers have been sold for $150-200M each. Since the program's inception, more than 60 PRVs have been awarded for 40 pediatric diseases, all at no cost to taxpayers. Longeveron is evaluating its stem cell therapy laromestrocel as a potential adjunct therapy for Hypoplastic Left Heart Syndrome, a rare pediatric congenital heart birth defect in which the left ventricle is either severely underdeveloped or missing. Even with current standard of care surgeries, only 50% of infants survive to adolescence due to right ventricular failure.