NeuroNOS (Beyond Air unit) receives FDA Orphan Drug Designation for BA-101 in glioblastoma

Beyond Air, Inc.

• FDA grants Orphan Drug Designation for BA-101, an investigational nNOS inhibitor, for treatment of glioblastoma.
• This is NeuroNOS's second orphan drug designation; ODD provides tax credits, fee waivers, and 7-year market exclusivity if approved.
• GBM median survival is <12 months; standard of care (surgery, radiation, temozolomide) is not curative.
• NeuroNOS CEO cites urgent unmet need and NO modulation strategy; preclinical data showed NOS inhibition reduced GBM cell proliferation.
• Company plans to advance BA-101 toward first-in-human studies.