An announcement from Neuren Pharmaceuticals Limited ( (AU:NEU) ) is now available.
Neuren Pharmaceuticals has initiated the development of NNZ-2591 to treat hypoxic-ischemic encephalopathy (HIE) in newborns, a severe brain injury caused by inadequate oxygen or blood flow. This condition affects thousands of infants globally and is a leading cause of neonatal death and disability. Currently, the only treatment is hypothermia, which has limited effectiveness. Neuren aims to offer a more comprehensive solution with NNZ-2591, which has shown promise in preclinical models and may qualify for Orphan Drug and Rare Pediatric disease designations from the FDA. The company plans a pre-IND meeting with the FDA in late 2025, aiming to improve long-term outcomes for affected children.
More about Neuren Pharmaceuticals Limited
Neuren Pharmaceuticals is focused on developing new drug therapies for serious neurological disorders that emerge in early childhood, with a particular emphasis on conditions that have no or limited approved treatment options. The company has received ‘orphan drug’ designation in the United States for its programs, which provides incentives for developing treatments for rare diseases. Neuren’s notable products include DAYBUE™ (trofinetide), approved for Rett syndrome, and NNZ-2591, which is in development for multiple neurodevelopmental disorders.
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