Beyond Air (XAIR) recently was surging during Monday's after-hours session, with shares recently climbing over 21%, after saying the US Food and Drug Administration has issued an orphan drug designation for its BA-102 lead investigational therapy for the treatment of Phelan-McDermid syndrome associated with autism spectrum disorder.
The company, through its NeuroNOS biopharmaceutical unit, is expecting to begin phase 1 testing of BA-102 in US for autism spectrum disorder in 2026.
Phelan-McDermid syndrome is a rare genetic disorder most commonly caused by deletions or mutations affecting the SHANK3 gene and leading to a range of symptoms, including global developmental delay, intellectual disability and severe speech impairments. There are no FDA-approved treatments for the syndrome at this time.
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