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XORTX Therapeutics Inc.
XORTX Therapeutics plans to file a Clinical Trial Application (CTA) with Health Canada for its gout therapeutic candidate, XRx-026 (XORLO). This initiative aims to accelerate the collection of clinical data to support a planned New Drug Application (NDA) with the U.S. FDA and expand the company's global regulatory strategy.…more
XORTX Therapeutics Inc.
XORTX Therapeutics plans to submit an Investigational New Drug (IND) application to the U.S. FDA for its gout treatment candidate, XRx-026, in the fourth quarter of 2026. This submission aims to advance the company's regulatory pathway toward a New Drug Application (NDA) and target the U.S. gout market, which is estimated at over $700 million annually.…more
XORTX Therapeutics Inc.
XORTX Therapeutics has initiated the clinical and commercial manufacturing of its gout treatment candidate, XORLO. This production process is a foundational step to support the XRX-OXY-102 clinical study and to generate the validation and stability data required for future US FDA marketing approval.…more
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XORTX Therapeutics Jumps 22% on Gout Drug Clinical Trial Filing
XORTX Therapeutics shares surged after the company announced plans to file a Clinical Trial Application with Health Canada for its gout drug candidate. The company expects this Canadian study to accelerate its future New Drug Application process with the FDA.…more
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XORTX Therapeutics announced its plan to file a Clinical Trial Application with Health Canada for its gout treatment candidate, XRx-026. This move is intended to accelerate the company's clinical data collection to support a future New Drug Application with the U.S. FDA.…more
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XORTX Therapeutics announced plans to submit an Investigational New Drug (IND) application to the FDA for its gout treatment, XRx-026, in the fourth quarter of 2026. While the company aims to move toward a New Drug Application (NDA), the timeline remains subject to clinical trial success and sufficient funding.…more
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