Biotech MAIA soars 26% as potential FDA approval means 'inflection point'

Shares of MAIA Biotechnology, a micro-cap developer of a cancer drug designed to “trick” tumor cells, surged 26% on Monday, January 20, to their highest level since May 2025. The company’s lead therapy is moving closer to potential regulatory approval in the U.S., which MAIA described as a “clear value-creation inflection point” for shareholders.

MAIA shares jumped 26.4% to $2.20 per share on the New York Stock Exchange on Tuesday, marking their highest level since May.

Investors reacted to the company’s announcement that the U.S. Food and Drug Administration could approve its first drug, which targets certain cancers, within 18-24 months.

Approval would allow MAIA to begin commercializing its therapy, addressing what the company estimates to be a market exceeding $50 billion. MAIA does not yet have any FDA-approved drugs and currently finances its operations primarily through stock offerings and grants.

Regulatory approval of the company’s lead candidate would represent a "clear value-creation inflection point, with meaningful long-term benefits for stockholders," according to MAIA founder and CEO Vlad Vitoc, whose comments were quoted in the company’s announcement.

Founded in 2018, MAIA Biotechnology focuses on developing novel cancer therapies. Its lead drug candidate, ateganosine, also known as THIO, targets telomeres, the protective caps at the ends of chromosomes. By acting on telomeres, the drug causes the telomeres to break apart, the cancer cell DNA to unwind, and the tumor cell to die, Vitoc explained in an interview with Oncology Compass.

MAIA is studying the drug across several cancer indications, with its most advanced program in non-small cell lung cancer, or NSCLC, which accounts for about 85% of all lung cancer cases. For this indication, the FDA granted ateganosine Fast Track status, enabling the company to run phase II and phase III trials in parallel. According to Vitoc, strong interim phase III data could support early full commercial approval.

The company also plans to begin research this year on second-generation molecules that are expected to deliver improved efficacy versus ateganosine.

MAIA shares are up about 10% over the last 12 months.

Only a single Wall Street analyst currently covers the company, according to MarketWatch data. The analyst has a “buy” rating on the stock and a target price of $14 per share, implying upside of 540% from current levels.