XRTX - Xortx stock climbs on FDA orphan drug status for kidney disease therapy

2023-04-21 07:25:44 ET

The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Xortx Therapeutics' ( NASDAQ: XRTX ) Xorlo (oxypurinol) to treat autosomal dominant polycystic kidney disease (ADPKD).

Polycystic kidney disease is an inherited disorder in which clusters of cysts develop mainly in the kidneys, causing the organ to enlarge and lose function over time.

"Orphan drug designation represents a major milestone for the Company in pursuit of marketing approval for XORLO, our proprietary formulation of oxypurinol, and the XRx-008 program for ADPKD," said CEO Allen Davidoff. "Further our potential partners indicated that it was a critical requirement underpinning their consideration of the XORLO program."

In February, the company had filed an orphan drug designation request to the FDA for XRx-008 program to treat ADPKD.

Davidoff added that the company was looking forward to its meeting with the FDA on May 1 to discuss a planned phase 3 program for the drug.

The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.

XRTX +4.04% to $0.78 premarket April 21

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