ateganosine (THIO; 6-thio-2'-deoxyguanosine) — FDA meeting
2026
Engage in regulatory interactions with the FDA .Source filing
MAIA biotech catalysts & pipeline
MAIA BIOTECHNOLOGY INC · Data as of 2026-10-25
Upcoming catalysts
ateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2026
Based on the clinical data generated by our THIO-101 trial, we plan to seek filing for an accelerated approval of ateganosine in the United States for the treatment of patients with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA).Source filing
ateganosine (THIO; 6-thio-2'-deoxyguanosine) — Interim data
2027
Interim data from the Phase 3 trial, expected next year, may support a discussion with the FDA to present our case for early full commercial approval in third-line NSCLC.Source filing
ateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2027
We initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028.Source filing
ateganosine (THIO; 6-thio-2'-deoxyguanosine) — NDA/BLA submission
2028
We initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing for full commercial approval in 2028.Source filing