MAIA soars after its cancer drug receives FDA ‘rare pediatric disease’ designation
Quotes on MAIA Biotechnology shares jumped 6.4% in U.S. premarket trading today, Tuesday, December 17, following a 10.0% surge the previous day. This came after the company announced that the FDA had granted a special designation to its drug for pediatric brain tumors. The designation came with a voucher that can be redeemed to receive priority review for another drug or sold for hundreds of millions of dollars.
Details
In U.S. premarket trading today, MAIA Biotechnology stock gained 6.4% as of this writing to $2.34 per share, a level it had not seen in a regular session in almost a month — since November 19. Today’s gains followed a 10% jump on Monday. Since the start of the year, MAIA stock is up 88%.
Yesterday, MAIA announced that the FDA had designated its THIO, which treats pediatric-type diffuse high-grade gliomas (a type of tumor that forms in the brain or spinal cord), as a drug for a “rare pediatric disease.” This designation qualifies MAIA for a voucher that allows the company to receive priority FDA review of a different product in its pipeline. This is supposed to incentivize the development of drugs for rare pediatric diseases. The voucher may also be “sold as an asset at a very high valuation,” said MAIA Vice President K. Robinson Lewis, as cited in the press release.
Why MAIA matters
High-grade gliomas are tumors of the central nervous system that originate from transformed cells of the brain or the spinal cord. While rare in children under three years old, they account for 15-20% of all pediatric brain tumors. Without treatment, survival is only a few months.
High-grade gliomas are among the most treatment-resistant cancers in children, noted MAIA CEO Vlad Vitoc. Standard treatments include surgery, chemotherapy, and radiation therapy. MAIA’s drug takes a different approach by infiltrating cancer cells and destroying them from within.
The company is also studying its drug for three other cancer types: hepatocellular carcinoma, small-cell lung cancer, and glioblastoma.
About priority review vouchers
A priority review voucher can be used in mergers and acquisitions or sold, with proceeds going toward the development of other drugs. The law firm Venable estimated that, on average, 5-10 vouchers are sold annually, as noted by Pharmaceutical Technology magazine in a January feature. GlobalData put the average price of a voucher at $100 million.
According to Pharmaceutical Technology, the first-ever priority review voucher sold was by BioMarin to Regeneron Pharmaceuticals for $67.5 million. The latter used it to expedite FDA approval of its cholesterol-lowering drug, gaining a one-month advantage over rival Amgen. In 2015, the pharmaceutical company AbbVie purchased a priority review voucher from United Therapeutics for $350 million, the highest price ever paid for one, according to Pharmaceutical Technology.
However, voucher prices have been declining recently due to a proliferation of vouchers and a lack of venture capital, Venable partner Jeremiah Kelly told Pharmaceutical Technology. The FDA has announced that the voucher program would end in December 2024.
Analyst insights
According to MarketWatch, the one analyst who covers MAIA rates it a “buy,” with a target price of $14 per share, more than six times the last closing price.
