XORTX Therapeutics (XRTX) has submitted a Type C meeting request with the US Food and Drug Administration regarding the Company’s XRx-026 program for the treatment of gout. Development of XORLO 1, the Company’s proprietary drug formulation of oxypurinol, has advanced to the point where a Type C meeting and discussion with the FDA is warranted. The purpose of this meeting is to review the XRx-026 program and its readiness for submission of a New Drug Application to gain marketing approval for XORLO in the US using the FDA’s 505(b)2 development pathway. The Company will provide updates on the progress of the XRx-026 gout program when additional information is available.
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