Xortx Therapeutics Inc Stock Price, News & Analysis

XORTX (NASDAQ: XRTX) announced a registered direct offering of 1,746,631 common shares (or equivalents) at US$0.63 per share, for gross proceeds of approximately US$1.1 million. Closing is expected on or about October 22, 2025, subject to customary closing conditions and TSX Venture Exchange approval. Net proceeds are intended for working capital and general corporate purposes. D. Boral Capital is sole placement agent. Shares will be issued under an effective Form F-3 shelf registration declared effective by the SEC on February 3, 2023. A prospectus supplement will be filed with the SEC.

XORTX (NASDAQ: XRTX) notified investors that a press release reissued in error should be disregarded and that Nasdaq granted the company a 180-day extension to regain compliance with the minimum $1.00 bid price requirement under Nasdaq Rule 5550(a)(2).

The company was first found non-compliant on April 17, 2025 and had until October 14, 2025; the new deadline is April 13, 2026. If the closing bid is at least $1.00 for 10 consecutive business days during the extension, Nasdaq will notify XORTX that the deficiency is closed. If compliance is not demonstrated by April 13, 2026, Nasdaq will notify XORTX of delisting and the company may appeal to a Nasdaq Hearings Panel while remaining listed pending the Panel’s decision.

XORTX (NASDAQ: XRTX) received a Nasdaq notice on October 20, 2025 that it is not in compliance with the minimum $1.00 bid price requirement under Nasdaq Rule 5550(a)(2) after the closing bid fell below $1.00 for 30 consecutive business days.

The company has a 180-calendar-day cure period from the notification date to regain compliance while the shares continue to trade on the Nasdaq Capital Market. Regaining compliance requires the bid price to close at or above $1.00 for a minimum of 10 consecutive business days (subject to Nasdaq discretion). XORTX said it will evaluate options to resolve the deficiency; the notice does not affect its TSX Venture Exchange listing.

XORTX (NASDAQ: XRTX) entered a binding term sheet to acquire a renal anti-fibrotic therapeutic program from Vectus, including a novel new chemical entity VB4-P5, associated intellectual property, regulatory documentation, and manufacturing data.

The program is at the pre-IND stage. Consideration is USD $3.0 million payable in XORTX common shares or equivalents at a deemed issue price of USD $0.86 per security, subject to adjustment and TSXV pricing rules. Closing is targeted within 90 days and Vectus will be subject to a 180-day lockup.

XORTX Therapeutics (NASDAQ: XRTX) will host an investor webinar and Q&A session on September 10, 2025, at 4:15 pm ET. The event, hosted by RedChip Companies, will feature CEO Dr. Allen Davidoff discussing the company's innovative therapies for cardiorenal conditions.

Key highlights include XRx-026 (XORLO™), their late-stage program for allopurinol-intolerant gout, with NDA filing planned for H1 2026. The company estimates a $700 million annual market opportunity for XORLO™. The presentation will also cover other pipeline candidates including XRx-008 for ADPKD, XRx-101 for acute kidney injury, and XRx-225 for diabetic nephropathy.

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.