MAIA Biotechnology granted FDA rare pediatric disease designation for THIO

MAIA Biotechnology (MAIA) earlier announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas as a drug for a “rare pediatric disease.” MAIA’s Vice President and Head of Regulatory and Quality K. Robinson Lewis said, “Rare pediatric disease designation also offers a highly valuable incentive for MAIA. Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed or sold as an asset at a very high valuation.” The company added: “Rare pediatric disease priority review vouchers can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor. Since 2015, FDA priority review vouchers have sold as assets at an average amount of $100M.” In afternoon trading, shares of MAIA are up 25c, or 12%, to $2.25.