The U.S. Food and Drug Administration has granted Fast Track status to MAIA Biotechnology’s ateganosine (also known as THIO), an investigational treatment for non-small cell lung cancer. The designation is intended to speed development and review of drugs that address serious conditions and unmet medical needs, and can open the path to accelerated approval and priority review. Ateganosine is a first-in-class small-molecule agent that targets telomeres in cancer cells and is being studied in the pivotal Phase 2 THIO-101 trial. Interim data released in May showed a median overall survival of 17.8 months in heavily pre-treated NSCLC patients, compared with historical survival of roughly 5–6 months on existing chemotherapy regimens. The drug is being tested in combination with the PD-1 inhibitor cemiplimab (Libtayo). MAIA said a successful Fast Track pathway could lead to an FDA decision as early as next year, giving the company a potential first-to-market position in a global NSCLC therapy segment valued at about $34 billion in 2024. MAIA shares rose between 6% and 11% in early trading following the announcement.