---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-021105"
form_type: "8-K"
ticker: "MAIA"
cik: "0001878313"
company_name: "MAIA Biotechnology, Inc."
filed_at: "2025-07-28T23:59:59+00:00"
generated_at: "2026-05-18T00:25:56.991078+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# MAIA Biotech gets FDA Fast Track for ateganosine in NSCLC; Phase 2 data shows 17.8-month median OS

## Summary
- FDA granted Fast Track designation for ateganosine (THIO) for treatment of non-small cell lung cancer.
- Phase 2 THIO-101 trial showed median overall survival of 17.8 months in heavily pre-treated patients, vs. 5-6 months for standard of care.
- Ateganosine is a first-in-class small molecule telomere-targeting agent; if approved, could compete in $34B NSCLC market.
- Fast Track enables accelerated approval and priority review; FDA decision possible as early as next year.

## SEC filing metadata
- accession: 0001641172-25-021105
- form_type: 8-K
- ticker: MAIA
- cik: 0001878313
- company_name: MAIA Biotechnology, Inc.
- filed_at: 2025-07-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1878313/000164117225021105/0001641172-25-021105-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1878313/000164117225021105/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-021105
- JSON: https://secwatch.observer/filing/0001641172-25-021105.json
- Plain text: https://secwatch.observer/filing/0001641172-25-021105.txt

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