StreetInsider.com News Articles

XORTX plans FDA IND filing for gout drug in Q4 2026

Fri, 18 Sep 2026 08:05:29 -0400

XORTX Therapeutics Inc. (NASDAQ: XRTX) said it plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration for its XRx-026 gout program in the fourth quarter of 2026, according to a company statement.

The application covers XORLO, XORTX's proprietary formulation of oxypurinol, and will outline a clinical development plan that includes a two-part trial designated XRX-OXY-102. The trial is intended to characterize the pharmacokinetics and efficacy of XORLO to support a future New Drug Application filing.

Subject to sufficient funding and timely completion of the XRX-OXY-102 trial, the company said it is targeting an NDA submission in

Form 6-K XORTX Therapeutics Inc. For: Sep 18

Fri, 18 Sep 2026 08:05:00 -0400

si-local-file:///var/storage/secattach/20260918/27078391.html

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Fri, 18 Sep 2026 08:05:00 -0400

CALGARY, Alberta, Sept. 18, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, outlines its anticipated Investigational New Drug application (“IND”) submission to the U.S. Food and Drug Administration (the “FDA”) for the XRx-026 gout program. XORTX’s drug development plan is to seek FDA marketing approval for XRx-026 and provide patients with a new therapeutic option. The key steps the Company anticipates will be necessary to file a marketing application with the FDA include meetings with the

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Fri, 18 Sep 2026 08:05:00 -0400

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Fri, 18 Sep 2026 08:05:00 -0400

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Fri, 18 Sep 2026 08:05:00 -0400

Form 6-K XORTX Therapeutics Inc. For: Sep 10

Thu, 10 Sep 2026 16:18:00 -0400

si-local-file:///var/storage/secattach/20260910/27048682.html

XORTX begins manufacturing of gout drug candidate XORLO

Thu, 10 Sep 2026 16:07:51 -0400

XORTX Therapeutics Inc. (NASDAQ: XRTX) announced it has begun contract manufacturing of GMP drug substance and commercial-scale tablets of XORLO™, its proprietary formulation of oxypurinol, to support a planned clinical study and a future U.S. Food and Drug Administration marketing application.

The manufacturing activity is tied to the company's XRx-026 program for the treatment of gout. Production of pure oxypurinol drug substance, the active pharmaceutical ingredient in XORLO™, has started using the company's proprietary synthetic pathway. XORTX said it is working with a contract manufacturing partner toward commercial drug batch production.

The company stated that validation and stability data generated through this

XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

Thu, 10 Sep 2026 16:05:00 -0400

● Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval ●

CALGARY, Alberta, Sept. 10, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, announces the launch of production of drug material and tablet manufacturing to support the Company’s XRx-026 program for the treatment of gout. This manufacturing supports a planned two-part clinical study of XORLOTM, the Company’s proprietary formulation of

XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

Thu, 10 Sep 2026 16:05:00 -0400

● Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval ●

XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

Thu, 10 Sep 2026 16:05:00 -0400

● Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval ●

XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

Thu, 10 Sep 2026 16:05:00 -0400

● Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval ●

XORTX Re-Engages Investor Relations Program

Tue, 08 Sep 2026 18:15:00 -0400

CALGARY, Alberta, Sept. 08, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) announces that, following completion of its previously announced voluntary delisting from the TSX Venture Exchange, XORTX has re-engaged IR Agency LLC pursuant to a consulting agreement providing for investor relations and marketing services on substantially the same terms previously disclosed by the Company in its news releases dated May 19, 2026 and August 28, 2026.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead program XRx-026

XORTX Re-Engages Investor Relations Program

Tue, 08 Sep 2026 18:15:00 -0400

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead program XRx-026

XORTX cancels $2.5M investor relations deal, delays TSXV delisting

Fri, 28 Aug 2026 07:01:23 -0400

XORTX Therapeutics Inc. (NASDAQ: XRTX) has terminated its investor relations agreement with IR Agency LLC, originally signed May 13, 2026, and has had the full $2.5 million fee returned, according to a company statement.

The agreement, which had a 90-day term beginning May 18, 2026, was rescinded by mutual consent effective August 7, 2026. The contract had provided for 10 marketing days of news distribution campaigns for an aggregate fee of $2.5 million, described as fully earned upon receipt and non-refundable. Despite that term, the funds were returned to XORTX on August 14, 2026. The fee had been drawn from proceeds

Form 6-K XORTX Therapeutics Inc. For: Aug 28