XORTX Therapeutics Inc. (NASDAQ:XRTX) shares gained 16.11% to $2.45 in after-hours trading on Thursday after the Canada-based late-stage clinical biopharmaceutical company announced a key manufacturing milestone for its lead gout program.
Manufacturing Push Advances Pipeline
XORTX said it has launched production of drug material and tablets to support its XRx-026 program, targeting gout. The work backs a planned two-part clinical study, XRX-OXY-102, testing XORLO™, the company’s proprietary oxypurinol formulation and a xanthine oxidase inhibitor.
The company said that contract manufacturing of the active pharmaceutical ingredient, using XORTX’s proprietary synthetic process, is now underway. The company expects the resulting validation and stability data to support a future New Drug Application (NDA) submission to the Food and Drug Administration.
Co-CEO Dr. Allen Davidoff called it “a foundational step toward bringing XORLO™ to patients,” adding that the work builds the validation and stability record the company expects will support its NDA filing.
