Xortx Therapeutics Inc Stock Price, News & Analysis

XORTX Therapeutics (NASDAQ: XRTX) has initiated the preparation of an Investigational New Drug (IND) application for XRx-026 (XORLO™), their proprietary formulation of oxypurinol targeting gout treatment. The company has partnered with Allucent, a global CRO, to support the regulatory submission process.

Following an April 2025 Type B meeting with the FDA, the company received guidance outlining four key requirements for NDA submission: IND filing, preparation of drug supply with stability data, a pharmacologic study of XORLO™ in fasted versus fed states, and final data compilation. The company expects to submit the IND in H2 2025.

Additionally, XORTX reported issuing 73,871 common shares at US$1.54 per share under their ATM offering, generating gross proceeds of US$113,547.

XORTX Therapeutics (NASDAQ: XRTX) has provided a comprehensive corporate update and strategic roadmap for 2025/2026, highlighting significant progress in its gout treatment program. The company's lead product, XORLO™, an oral oxypurinol formulation, is approximately 12 months away from filing a New Drug Application (NDA) with the FDA, targeting a $700 million annual market opportunity.

Key 2025 achievements include successful FDA Type B meeting completion, advancement of the XRX-OXY-101 pharmacokinetics trial, securing European patent protection, and raising $925,000 through a non-brokered LIFE offering. The company strengthened its leadership with strategic appointments and validated its XORLO™ formulation.

For 2025/2026, XORTX plans to submit an IND application, initiate the XRX-OXY-102 clinical trial, scale up manufacturing, prepare for commercialization, and develop European market strategy, subject to funding availability.

XORTX Therapeutics (NASDAQ: XRTX) has announced a non-brokered private placement to raise USD $3 million through the issuance of up to 3,409,090 common share units at USD $0.88 per unit. Each unit includes one common share and one warrant exercisable at USD $1.20 per share for 60 months. The warrants include an acceleration clause if the stock trades above USD $2.00 for 10+ consecutive days.

The proceeds will be used to advance XORTX's gout treatment programs and for working capital purposes. The offering is subject to TSX Venture Exchange approval, and securities will have a four-month hold period. The company plans to file a Form F-1 registration statement within 30 days of closing.

XORTX Therapeutics has received crucial FDA feedback regarding their new drug application (NDA) for XORLO™, a novel oxypurinol formulation targeting gout treatment. The Type B meeting with FDA reviewed chemistry, manufacturing, pharmacology, toxicology, and clinical evidence for the XRx-026 program.

The company will proceed with five key steps:

• Finalizing FDA meeting minutes
• Filing an Investigative New Drug application
• Characterizing pharmacokinetics of XORLO™ commercial tablet
• Manufacturing and validating commercial drug supplies
• Preparing and filing the NDA

XORTX aims to file the gout NDA in H1 2026, advancing through the FDA 505(b)2 development pathway. The company, which focuses on innovative therapies for gout and progressive kidney disease, will provide updates once FDA meeting minutes are finalized.

XORTX Therapeutics (NASDAQ: XRTX) has announced the granting of a European patent for 'Xanthine Oxidase Inhibitor Formulations.' The patent covers compositions and methods for formulating the company's proprietary XOI formulations to treat conditions related to high uric acid, including gout, renal, and cardiovascular diseases.

This patent strengthens XORTX's intellectual property portfolio in the EU and provides broader protection for their first-in-class gout program and autosomal dominant polycystic kidney disease (ADPKD) program. The patent specifically addresses health consequences arising from uric acid crystal formation due to hyperuricemia.

With this addition, XORTX now holds five granted patents in the United States and/or EU, covering compositions and uses of uric acid lowering agents for treating gout, hyperuricemia consequences, and progressive kidney disease.

XORTX Therapeutics (NASDAQ: XRTX) has received notification from Nasdaq that it is not complying with the minimum bid price requirement, as its shares traded below US$1.00 for 30 consecutive business days. The company has been granted 180 calendar days to regain compliance with Nasdaq Rule 5550(a)(2).

To resolve this deficiency, XORTX must maintain a closing bid price of US$1.00 or higher for a minimum of 10 consecutive business days. The notification does not immediately affect XORTX's listing on the Nasdaq Capital Market or its status on the TSX Venture Exchange. The company is currently evaluating options to address this compliance issue.

XORTX Therapeutics (NASDAQ: XRTX) has announced an upcoming Type B meeting with the FDA regarding their XRx-026 program for gout treatment. The company will submit a meeting package to the FDA within a week, with FDA communications expected by April 26, 2025.

The comprehensive review will cover chemistry, manufacturing, pharmacology, toxicology, and clinical evidence for XORLOTM, their proprietary oxypurinol drug formulation. The meeting aims to assess the program's readiness for a New Drug Application (NDA) through the FDA 505(b)2 development pathway.

The company believes this Type B meeting will facilitate broader discussions toward market approval, potentially transforming XORTX to a revenue-positive state by providing a new therapeutic option for gout patients.

XORTX Therapeutics (NASDAQ: XRTX) has submitted a Type C meeting request with the FDA regarding its XRx-026 program for gout treatment. The meeting aims to review the program's readiness for a New Drug Application (NDA) to gain marketing approval for XORLO™, the company's proprietary oxypurinol formulation, using the FDA's 505(b)2 development pathway.

The company has completed previously requested FDA work on oxypurinol and expects the meeting to be held within 75 days of the request. Management views this program as potentially revenue-positive within two years, targeting individuals with gout who have therapeutic options.

XORTX Therapeutics (NASDAQ: XRTX) has announced its participation and presentation at the Microcap Conference in Atlantic City, NJ, from January 28-30, 2025. The company will present on January 29, focusing on two key programs: the XRx-026 program for gout and its planned New Drug Application (NDA) filing, along with updates on the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD) and its registration clinical trial preparations.

CEO Dr. Allen Davidoff highlighted that the conference will provide opportunities for one-on-one meetings with new investors and allow the company to present its overview to conference attendees. The presentation will be recorded and made available on the company's website post-conference.