MAIA Biotechnology Reports FDA's Fast Track Designation For Ateganosine

(RTTNews) - MAIA Biotechnology (MAIA) announced that the FDA has granted Fast Track designation for ateganosine for the treatment of non-small cell lung cancer. Ateganosine is currently being evaluated in a Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

MAIA CEO Vlad Vitoc, said: "If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need."

Shares of MAIA Biotechnology are up 8% in pre-market trade on Monday.

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