Maia Biotechnology Inc (AMEX:MAIA) saw its stock surge 11.2% in pre-market trading following the announcement that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its cancer drug ateganosine.
This designation, given for the treatment of non-small cell lung cancer (NSCLC), could speed up the drug’s regulatory review process. Ateganosine is currently in a pivotal Phase 2 clinical trial assessing its anti-tumor effects when used prior to a checkpoint inhibitor.
The drug targets telomere structure and function in cancer cells, leading to tumor elimination and the development of specific immune memory. By acting through telomerase, ateganosine aims to overcome resistance to immune checkpoint inhibitors.
MAIA Chairman and CEO Vlad Vitoc stated, “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.”
Recent results from the Phase 2 THIO-101 trial showed a median overall survival of 17.8 months in a heavily pre-treated patient group, compared to the typical 5 to 6 months seen with standard chemotherapy in similar cases.
NSCLC represents a sizable market opportunity, valued at $34.1 billion in 2024 and forecasted to grow to $68.8 billion by 2033, with an 8.1% compound annual growth rate.
The FDA’s Fast Track program aims to support the development and expedite the review of treatments addressing serious conditions with unmet medical needs, potentially allowing for accelerated approval and priority review of the drug.
Maia Biotechnology stock price
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