NeuroNOS Receives FDA's Orphan Drug Designation For BA-102 In Treating Rare Phelan-McDermid Syndrome

(RTTNews) - NeuroNOS, a subsidiary of Beyond Air (XAIR), announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead investigational therapy, BA-102, for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with Autism Spectrum Disorder (ASD). The company is on track to initiate first-in-human clinical trials for Autism Spectrum Disorder in the United States in 2026.

Phelan-McDermid Syndrome is a rare genetic disorder most commonly caused by deletions or mutations affecting the SHANK3 gene leading to a range of symptoms, including global developmental delay, intellectual disability, severe speech impairments, and in many cases features of ASD. Currently, there are no FDA-approved treatments specifically indicated for Phelan-McDermid Syndrome.

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