Home  »  US Market Overview   »  On What Basis Did XORTX Therapeutics (XRTX) Stock ...

On What Basis Did XORTX Therapeutics (XRTX) Stock Rise 9% During Extended Session On Tuesday?

Following a no letter from Canadian regulators, XORTX Therapeutics Inc. (NASDAQ: XRTX) shares increased 9.21% to $0.83 on Tuesday after-hours trading.

What letter has XRTX received?

Health Canada recently sent a second no objection letter (NOL) addressing the company’s ongoing XRX-OXY101 clinical bridging pharmacokinetics trial (the “Study”) to XORTX Therapeutics (XRTX). The study was initially intended to be a three-part study, and Health Canada got an NOL in April. Parts 1 and 2 of the Study have been successfully completed by XORTX. Part 3 has been updated, and Part 4 has been added.

Will You Miss Out On This Growth Stock Boom?

A new megatrend in the fintech market is well underway. Mobile payments are projected to boom into a massive $12 trillion market by 2028. According to Motley Fool this growth stock could "deliver huge returns." Not only in the immediate future but also over the next decade. Especially since the man behind this company is a serial entrepreneur who has been wildly successful over the years.

And this is just one of our 5 Best Growth Stocks To Own For 2023.

Sponsored

XRX-original OXY-101’s design had three goals: figuring out which of XORTX’s novel formulations produces the highest levels of oxypurinol in the bloodstream; figuring out how food affects this formulation’s bioavailability; and figuring out the safety and pharmacokinetics of multiple doses of this chosen formulation. Following the completion of parts 1 and 2, XRTX revised part 3 to add a new characterization of the impact of meals, and it added a fourth aim, part 4, to describe the amount of oxypurinol absorbed after three successively higher doses of XRx-008. In order to assist the Company’s upcoming phase 3 registration study in Autosomal Dominant Polycystic Kidney Disease (“ADPKD”), information gathered over the course of this trial will give recommendations about the oral dose of oxypurinol formulations in the future. Additionally, this study will offer information to assist upcoming NDA (New Drug Application) marketing filings to the European Medicines Agency and the US Food and Drug Administration (“FDA”).

How will the letter enable XRTX to move forward?

Health Canada granted XORTX Therapeutics (XRTX) the NOL for the revised pharmacokinetic study since the study has so far demonstrated that the unique, proprietary xanthine oxidase formulation XRx-008 has a significantly enhanced bioavailability. The Part 3 and 4 designs can move forward, according to this Health Canada NOL. The Study’s two components will be carried out concurrently. Notably, part 3’s successful screening has been finished, and dosing will soon start while part 4’s screening is in progress. Tablets comparable to those that will be used in its phase 3 registration trials will be used to medicate participants in Parts 3 and 4. The Study’s conclusion will assist the XRx-008 program through FDA 505(b)2 development, its next phase 3 registration study, and ultimately toward marketing approval for the treatment of those with progressive kidney disease caused by ADPKD.

Leave a Comment

Your email address will not be published. Required fields are marked *

On Key

Related Posts

5 Lithium Stocks with High Future Potential

Demand for lithium is expected to increase 8-fold by 2030. The world's largest automakers are racing to go green as the global EV boom continues.

 

We have collated a list of top five lithium stocks which are well positioned to benefit from the 2023 lithium boom because of their focus on multiple high-potential lithium projects.

100% free. stop anytime no spam