XORTX Therapeutics Inc. - XRTX STOCK NEWS

XORTX Therapeutics Inc. (NASDAQ: XRTX) announced that its President and CEO, Dr. Allen Davidoff, will speak at several upcoming investor conferences. These include the Sidoti & Company LLC Micro-Cap Virtual Conference on November 9-10, the A.G.P. Virtual Biotech Conference on November 30-December 1, and Singular Research's Best of the Uncovereds Conference on December 8 in San Francisco. XORTX is focused on developing innovative therapies for progressive kidney disease, including drugs like XRx-008 for ADPKD and XRx-101 for COVID-19 related organ injury.

XORTX Therapeutics announced receiving a new no objection letter from Health Canada regarding its XRX-OXY-101 clinical study for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study has been amended to include new objectives, including assessing food effects on the drug's bioavailability and characterizing different doses. CEO Dr. Allen Davidoff highlighted increased bioavailability of XRx-008. The findings will support the upcoming phase 3 trial and regulatory submissions to the FDA and EMA.

XORTX Therapeutics Inc. (NASDAQ: XRTX) announced the online availability of a peer-reviewed abstract for the ASN Kidney Week 2022 conference. The study, highlighting the effects of elevated uric acid on polycystic kidney disease (PKD) in rodent models, indicates that increased uric acid leads to significant kidney damage, evidenced by increased kidney weight, creatinine levels, and cyst index. The findings support the company's XRx-008 program aimed at treating ADPKD and could enhance its patent portfolio. The presentation will be by Dr. Charles Edelstein and Dr. Allen Davidoff on November 4, 2022.

XORTX Therapeutics has completed a public offering, raising US$5 million through the sale of 1.4 million Common Share Units at US$1.00 each and 3.6 million Pre-Funded Units at US$0.9999 each. This offering includes common shares and warrants, allowing immediate separability upon issuance. Additionally, the company reduced the exercise price of prior warrants from US$4.77 to US$1.17. The registration statement was declared effective on September 22, 2022.

XORTX Therapeutics Inc. (NASDAQ: XRTX) has announced a public offering of 1.4 million common share units priced at $1.00 each, alongside 3.6 million pre-funded warrant units at $0.9999, aiming for gross proceeds of $5 million. The offering is set to close by October 6, 2022, pending customary conditions. Additionally, the company plans to reduce the exercise price of outstanding warrants from $4.77 to $1.17 post-offering. A.G.P./Alliance Global Partners is the sole book-running manager for this offering.

XORTX Therapeutics Inc. (NASDAQ: XRTX) announced the successful completion of its Type B Pre-phase 3 meeting with the FDA on September 16, 2022. This meeting followed the submission of a comprehensive Pre-Phase-3 Briefing Package on July 28, 2022, outlining advancements in the XRx-008 program for treating autosomal dominant polycystic kidney disease (ADPKD). The FDA's feedback focused on optimizing trial design with minimal concerns, paving the way for a single phase 3 clinical trial aimed at marketing approval. CEO Dr. Allen Davidoff emphasized the importance of FDA guidance in refining their clinical trial strategy.

XORTX Therapeutics announced the acceptance of a study abstract for presentation at the American Society of Nephrology Kidney Week 2022. The study, titled “Raising Serum Uric Acid with a Uricase Inhibitor Worsens PKD in Rat and Mouse Models”, reveals that increased serum uric acid can accelerate injury in Polycystic Kidney Disease (PKD). Dr. Charles Edelstein will present this finding, supporting XORTX’s XRx-008 program. The company anticipates further updates around the conference and aims to expand its patent portfolio based on these findings.

XORTX Therapeutics announced positive topline results from its Pharmacokinetics Bridging Study – XRX-OXY-101 Part 2, highlighting a significant increase in the oral bioavailability of its proprietary oxypurinol formulation when taken with food. The study also confirmed a clean safety profile with no drug-related adverse events. This successful study paves the way for the planned Phase 3 registration trial in autosomal dominant polycystic kidney disease (ADPKD), with patient dosing expected in the first half of 2023.

XORTX Therapeutics has filed a Pre-Phase 3 Meeting Briefing Package with the FDA regarding its XRx-008 program for treating autosomal dominant polycystic kidney disease (ADPKD). The virtual meeting is set for September 16, 2022. Recent R&D milestones include the manufacturing of clinical quality GMP oxypurinol and improvements in drug formulation. This progress positions XORTX favorably for key discussions with the FDA about essential clinical steps ahead of filing a New Drug Application (NDA).