- Xortx Therapeutics ( NASDAQ: XRTX ) said it submitted an orphan drug designation (ODD) request to the U.S. Food and Drug Administration (FDA) for XRx-008 program to treat Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- 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.
- The company noted that it plans to pursue these benefits as part of the drug development for XRx-008 to treat ADPKD, pending designation of the ODD request.
- 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.
- XRTX +9.15% to $0.64 premarket Feb. 1
For further details see:
Xortx stock rises on FDA filing for orphan drug status for kidney disease therapy