On December 10, 2025, MAIA Biotechnology, Inc. (MAIA) announced it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate ateganosine. The 8-K filing disclosed the designation applies to ateganosine for the treatment of non-small cell lung cancer (NSCLC) patients who are resistant to both immunotherapy and chemotherapy.

According to the filing, ateganosine is a telomere-targeting agent currently being evaluated in the Phase 3 THIO-104 trial for advanced NSCLC. The company also holds FDA Orphan Drug Designations for ateganosine for three additional oncology indications: glioblastoma, hepatocellular carcinoma (HCC), and small cell lung cancer (SCLC).

The filing provides market context, noting that checkpoint inhibitors (CPIs) in NSCLC generated approximately $50 billion in global sales in 2024. Merck's Keytruda (pembrolizumab), a PD-1 inhibitor, generated $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30 percent of its total sales. The NSCLC market was valued at $34.1 billion and is projected to nearly double to $68.8 billion by 2033.

For the other potential indications, the filing cites market sizes: the glioblastoma market is expected to grow from $2.2 billion to $3.2 billion, the hepatocellular carcinoma (HCC) market is valued at $3.8 billion, and the small cell lung cancer (SCLC) market is valued at $2.8 billion.