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XORTX Therapeutics Inc. develops therapies for gout and progressive kidney disease, with programs that include XRx-026 for gout, XRx-008 for autosomal dominant polycystic kidney disease, XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections, and XRx-225 for Type 2 diabetic nephropathy. The company also holds the VB4-P5 kidney anti-fibrotic program, a pre-IND asset targeting rare and prevalent forms of kidney disease.
Company announcements cover clinical and preclinical pipeline development, acquired kidney-disease assets, share consolidations, Nasdaq and TSX Venture Exchange listing matters, annual meeting results, board elections, auditor appointments, stock option plan approvals, and other governance actions tied to its public-company status.
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.
XORTX Therapeutics (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focusing on progressive kidney disease and gout treatments, has announced a change in its auditor. The company's board has accepted the resignation of Smythe LLP and appointed Davidson & Company LLP as the new auditor effective January 16, 2025.
The transition occurred without any reservations in the Former Auditor's reports or any reportable events. The required documentation, including the Notice of Change of Auditor and letters from both auditing firms, has been reviewed by the company's audit committee and board of directors, and filed on SEDAR+.
XORTX Therapeutics (NASDAQ: XRTX) has announced the launch of a new late-stage program, XRx-026, focused on treating individuals with gout who are intolerant to allopurinol. The company plans to initiate discussions with the FDA in the first half of 2025 regarding a New Drug Application (NDA) for this program.
The company will seek FDA orphan drug designation (ODD) for XRx-026, noting that oxypurinol was previously granted ODD for allopurinol intolerant gout. Clinical studies have demonstrated that oxypurinol is safe and effective in treating individuals with gout who cannot tolerate allopurinol, addressing an important unmet medical need for patients and physicians.
XORTX Therapeutics (NASDAQ: XRTX) has appointed Dr. Michael Bumby as its new Chief Financial Officer, replacing James Fairbairn. Dr. Bumby brings over 20 years of biotech/pharma industry experience, including a 14-year career at Eli Lilly and significant roles in public companies. He previously served as CFO at VIVO Cannabis and led Merus Labs' $340 million acquisition by Norgine B.V. in 2017.
Dr. Bumby holds a Doctor of Veterinary Medicine degree, a lean six-sigma blackbelt, and an MBA from the University of Toronto. The company has granted him 13,000 stock options at an exercise price of $1.75, valid for five years.
XORTX Therapeutics (NASDAQ: XRTX) announced a presentation at the Rare and Genetic Kidney Disease Summit in Boston on December 12, 2024. The presentation focuses on recent discoveries in Autosomal Dominant Polycystic Kidney Disease (ADPKD) and genetic factors influencing xanthine oxidase (XO) expression in kidney disease progression.
The research highlights how genetic factors affecting purine metabolism may act as a 'second hit' that accelerates ADPKD progression. This discovery explains why disease progression varies among family members and supports the development of personalized therapeutic approaches using XO inhibitors for at-risk individuals.
XORTX Therapeutics announced the acceptance of their abstract at the American Society of Nephrology, focusing on xanthine oxidase in polycystic kidney disease. The study, conducted at the University of Colorado and sponsored by XORTX, revealed significant findings in both rat and mouse PKD models. Key results showed that increased uric acid led to increased cyst growth, while xanthine oxidase inhibitor decreased serum uric acid and cyst growth. Clinical results from the Halt Clinical Trial - Group A demonstrated that patients with elevated serum uric acid experienced increased total kidney volume and faster PKD progression. Additionally, increased serum XO activity was linked to earlier onset of high blood pressure.
XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has closed its previously announced US$1.5 million registered direct offering and concurrent private placement. The offering included the sale of 810,810 common shares (or pre-funded warrants) at US$1.85 per share and common warrants to purchase up to 810,810 common shares. The warrants have an exercise price of US$2.18, are immediately exercisable, and expire in five years.
A.G.P./Alliance Global Partners acted as the sole placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The common shares were offered through an effective shelf registration statement, while the private placement of warrants was made under exemptions from registration requirements.
XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has announced a US$1.5 million registered direct offering and concurrent private placement. The company will sell 810,810 common shares (or equivalents) at US$1.85 per share and issue warrants to purchase up to 810,810 common shares at US$2.18 per share. The warrants will be immediately exercisable and expire in five years. The offering is expected to close around October 18, 2024, subject to conditions. A.G.P./Alliance Global Partners is acting as the sole placement agent. XORTX intends to use the net proceeds for working capital and general corporate purposes. The offering includes a registered direct offering under an effective shelf registration and a private placement of warrants.
XORTX Therapeutics Inc. (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) has initiated a precision medicine program following recent research linking genetic factors to xanthine oxidase (XO) over-expression in various diseases, including kidney disease. This initiative aims to combine genetic diagnostics with XO inhibition to target individuals most in need.
The company plans to develop diagnostic tools to identify specific genetic factors, which, combined with XORTX's expertise in developing unique formulations of uric acid lowering agents and XO inhibitors, will allow for tailored treatments for subpopulations with common susceptibilities or similar drug responses.
XORTX will begin evaluating individuals in their planned registration clinical trial for autosomal dominant polycystic kidney disease (ADPKD) patients, providing an opportunity to better understand the role of genetic factors in progressive kidney disease.