---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-012825"
form_type: "8-K"
ticker: "XAIR"
cik: "0001641631"
company_name: "Beyond Air, Inc."
filed_at: "2025-09-08T23:59:59+00:00"
generated_at: "2026-05-17T07:37:01.358623+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-25-012825
- form_type: 8-K
- ticker: XAIR
- cik: 0001641631
- company_name: Beyond Air, Inc.
- filed_at: 2025-09-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1641631/000149315225012825/0001493152-25-012825-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1641631/000149315225012825/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-012825
- JSON: https://secwatch.observer/filing/0001493152-25-012825.json
- Plain text: https://secwatch.observer/filing/0001493152-25-012825.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.